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Extended Release Niacin and Fenofibrate for the Treatment of Atherogenic Dyslipidemia in Obese Females

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ClinicalTrials.gov Identifier: NCT03615534
Recruitment Status : Completed
First Posted : August 6, 2018
Results First Posted : October 12, 2018
Last Update Posted : September 4, 2019
Sponsor:
Collaborator:
Al-Kindy College of Medicine
Information provided by (Responsible Party):
Lewai Sharki Abdulaziz, MSc PhD, Al-Kindy College of Medicine

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Conditions Atherogenic Dyslipidemia
Obesity Associated Disorder
Interventions Other: Therapeutic Lifestyle Changes
Other: Placebo
Drug: Fenofibrate
Dietary Supplement: Wax Matrix Extended Release Niacin (WMER Niacin)
Enrollment 161
Recruitment Details Obese females (BMI≥30 kg/m2), within the age of 20-60 years, attending the Obesity research and therapy unit of Al-Kindy College of Medicine, Baghdad, Iraq, throughout the period from 1st October 2014 to 15th March 2015, were screened for preliminary eligibility.
Pre-assignment Details Out of the 161 obese females settled for participation, Atherogenic dyslipidemia (AD) was diagnosed in 69(42.9%) patients, all of whom were enrolled in Therapeutic Lifestyle Changes (TLC) run-in period. AD was averted by TLC in 12(17.4%) patients. The remaining 57(82.6%) non-responding patients were randomly allocated to one of the four study arms.
Arm/Group Title Placebo Fenofibrate Monotherapy WMER Niacin Monotherapy Combination Therapy
Hide Arm/Group Description

Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch daily single placebo capsule for eight weeks.

Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.

Placebo

Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch 200mg daily single dose of fenofibrate (Lipanthyl® 200 mg micronized fenofibrate capsule, Abbott Laboratories Fournier) for eight weeks.

Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.

Fenofibrate

Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive a night-time 500 mg daily single dose of Wax Matrix Extended Release Niacin (WMER Niacin, ENDUR-ACIN®500mg, Endurance Products Company, Oregon USA) for one week, titrated up to 1000 mg by adding a daily morning-time ENDUR-ACIN®500mg tablet for the next seven weeks.

Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.

Wax Matrix Extended Release Niacin (WMER Niacin)

Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch 200mg daily single dose of fenofibrate for eight weeks, in combination with a night-time 500 mg daily single dose of WMER Niacin for one week, titrated up to 1000mg by adding a daily morning-time ENDUR-ACIN®500mg tablet for the next seven weeks.

Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.

Fenofibrate

Wax Matrix Extended Release Niacin (WMER Niacin)

Period Title: Overall Study
Started 14 15 14 14
Completed 12 15 14 13
Not Completed 2 0 0 1
Arm/Group Title Placebo Fenofibrate Monotherapy WMER Niacin Monotherapy Combination Therapy Total
Hide Arm/Group Description

Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch daily single placebo capsule for eight weeks.

Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.

Placebo

Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch 200mg daily single dose of fenofibrate (Lipanthyl® 200 mg micronized fenofibrate capsule, Abbott Laboratories Fournier) for eight weeks.

Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.

Fenofibrate

Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive a night-time 500 mg daily single dose of Wax Matrix Extended Release Niacin (WMER Niacin, ENDUR-ACIN®500mg, Endurance Products Company, Oregon USA) for one week, titrated up to 1000 mg by adding a daily morning-time ENDUR-ACIN®500mg tablet for the next seven weeks.

Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.

Wax Matrix Extended Release Niacin (WMER Niacin)

Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch 200mg daily single dose of fenofibrate for eight weeks, in combination with a night-time 500 mg daily single dose of WMER Niacin for one week, titrated up to 1000mg by adding a daily morning-time ENDUR-ACIN®500mg tablet for the next seven weeks.

Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.

Fenofibrate

Wax Matrix Extended Release Niacin (WMER Niacin)

Total of all reporting groups
Overall Number of Baseline Participants 12 15 14 13 54
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 15 participants 14 participants 13 participants 54 participants
36.2  (2.5) 37.3  (2.0) 36.6  (2.1) 40.2  (2.2) 37.6  (2.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 15 participants 14 participants 13 participants 54 participants
Female
12
 100.0%
15
 100.0%
14
 100.0%
13
 100.0%
54
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Body Mass Index (BMI)   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 12 participants 15 participants 14 participants 13 participants 54 participants
38.9  (2.1) 41.5  (1.7) 42.0  (1.7) 39.7  (1.8) 40.6  (1.8)
[1]
Measure Description:

Weight (in Kilograms) and Height (in Meters) were measured using a portable stadiometer with movable head piece typically mounted on balanced beam scale (Segma, Germany). Body mass index (BMI) is the relative weight for height and it was calculated according to formula bellow:

BMI=Weight (Kg) / Height2 (m)

1.Primary Outcome
Title Changes Serum Triglyceride Levels
Hide Description Assessments involve the measurement of serum Triglyceride (TG) level.
Time Frame Treatments effects were assessed by two events, baseline investigations conducted before randomization and end line investigations at the end of the eighth week of treatments.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Fenofibrate Monotherapy WMER Niacin Monotherapy Combination Therapy
Hide Arm/Group Description:

Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch daily single placebo capsule for eight weeks.

Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.

Placebo

Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch 200mg daily single dose of fenofibrate (Lipanthyl® 200 mg micronized fenofibrate capsule, Abbott Laboratories Fournier) for eight weeks.

Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.

Fenofibrate

Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive a night-time 500 mg daily single dose of Wax Matrix Extended Release Niacin (WMER Niacin, ENDUR-ACIN®500mg, Endurance Products Company, Oregon USA) for one week, titrated up to 1000 mg by adding a daily morning-time ENDUR-ACIN®500mg tablet for the next seven weeks.

Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.

Wax Matrix Extended Release Niacin (WMER Niacin)

Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch 200mg daily single dose of fenofibrate for eight weeks, in combination with a night-time 500 mg daily single dose of WMER Niacin for one week, titrated up to 1000mg by adding a daily morning-time ENDUR-ACIN®500mg tablet for the next seven weeks.

Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.

Fenofibrate

Wax Matrix Extended Release Niacin (WMER Niacin)

Overall Number of Participants Analyzed 12 15 14 13
Mean (Standard Error)
Unit of Measure: mg/dl
Baseline TG levels 223.1  (23.4) 241.2  (19.1) 227.0  (19.7) 267.2  (20.5)
Adjusted End line TG levels 220.2  (12.8) 133.7  (11.4) 164.0  (11.4) 136.1  (12.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Fenofibrate Monotherapy, WMER Niacin Monotherapy, Combination Therapy
Comments Multivariate Analysis of Covariance (MANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline TG level as a covariate, with further adjustments for baseline HDL-C, ApoA1levels.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments Results were evaluated in terms of adjusted end line TG levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.
Method MANCOVA
Comments Covariates appearing in MANCOVA model are evaluated at the following baseline values: TG= 240.4 mg/dl, HDL-C = 31.8 mg/dl, ApoA1 = 144.6 mg/dl.
2.Primary Outcome
Title Changes in Serum Lipoprotein Cholesterol Levels
Hide Description

Assessments involve the measurement of serum Total (TC), High density lipoprotein (HDL-C) and direct Low density lipoprotein (d-LDL-C) cholesterol levels.

Serum non HDL-C levels is calculated by subtracting HDL-C from TC. Serum Remnant cholesterol (RC) is calculated by subtracting HDL-C and d-LDL-C from TC.

Time Frame Treatments effects were assessed by two events, baseline investigations conducted before randomization and end line investigations at the end of the eighth week of treatments.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Fenofibrate Monotherapy WMER Niacin Monotherapy Combination Therapy
Hide Arm/Group Description:

Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch daily single placebo capsule for eight weeks.

Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.

Placebo

Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch 200mg daily single dose of fenofibrate (Lipanthyl® 200 mg micronized fenofibrate capsule, Abbott Laboratories Fournier) for eight weeks.

Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.

Fenofibrate

Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive a night-time 500 mg daily single dose of Wax Matrix Extended Release Niacin (WMER Niacin, ENDUR-ACIN®500mg, Endurance Products Company, Oregon USA) for one week, titrated up to 1000 mg by adding a daily morning-time ENDUR-ACIN®500mg tablet for the next seven weeks.

Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.

Wax Matrix Extended Release Niacin (WMER Niacin)

Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch 200mg daily single dose of fenofibrate for eight weeks, in combination with a night-time 500 mg daily single dose of WMER Niacin for one week, titrated up to 1000mg by adding a daily morning-time ENDUR-ACIN®500mg tablet for the next seven weeks.

Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.

Fenofibrate

Wax Matrix Extended Release Niacin (WMER Niacin)

Overall Number of Participants Analyzed 12 15 14 13
Mean (Standard Error)
Unit of Measure: mg/dl
Baseline TC 203.1  (11.4) 190.7  (9.3) 189.1  (9.6) 219.5  (10.0)
Baseline HDL-C 30.9  (2.1) 32.1  (1.7) 34.2  (1.8) 29.7  (1.8)
Baseline d-LDL-C 120.0  (7.5) 108.9  (6.2) 120.1  (6.4) 129.3  (6.6)
Baseline non HDL-C 172.3  (11.3) 158.6  (9.2) 154.9  (9.5) 189.7  (9.9)
Baseline RC 52.3  (8.4) 49.7  (6.8) 34.9  (7.1) 60.5  (7.3)
Adjusted End line TC 198.4  (7.4) 171.1  (6.7) 177.3  (6.6) 179.9  (6.4)
Adjusted End line HDL-C 32.0  (1.4) 37.2  (1.3) 38.3  (1.3) 42.8  (1.3)
Adjusted End line d-LDL-C 115.7  (6.6) 103.6  (5.9) 103.3  (5.9) 115.0  (6.2)
Adjusted End line non HDL-C 166.4  (7.7) 134.1  (6.9) 138.7  (6.9) 136.3  (7.2)
Adjusted End line RC 50.7  (4.8) 30.3  (4.3) 35.7  (4.3) 22.1  (4.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Fenofibrate Monotherapy, WMER Niacin Monotherapy, Combination Therapy
Comments Multivariate Analysis of Covariance (MANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline TC level as a covariate, with further adjustments for baseline Non HDL-C and d-LDL-C.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.060
Comments Results were evaluated in terms of adjusted end line TC levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.
Method MANCOVA
Comments Covariates appearing in MANCOVA model are evaluated at the following baseline values: TC=199.9 mg/dl, Non HDL-C= 168.0 mg/dl, d-LDL-C= 119.1 mg/dl.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Fenofibrate Monotherapy, WMER Niacin Monotherapy, Combination Therapy
Comments Multivariate Analysis of Covariance (MANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline HDL-C level as a covariate, with further adjustments for baselineTG, ApoA1levels.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments Results were evaluated in terms of adjusted end line HDL-C levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.
Method MANCOVA
Comments Covariates appearing in MANCOVA model are evaluated at the following baseline values: HDL-C = 31.8 mg/dL,TG= 240.4 mg/dL, ApoA1 = 144.6 mg/dL.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Fenofibrate Monotherapy, WMER Niacin Monotherapy, Combination Therapy
Comments Multivariate Analysis of Covariance (MANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline d-LDL-C level as a covariate, with further adjustments for baseline TC and Non HDL-C .
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.334
Comments Results were evaluated in terms of adjusted end line d-LDL-C levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.
Method MANCOVA
Comments Covariates appearing in MANCOVA model are evaluated at the following baseline values: d-LDL-C= 119.1 mg/dl.TC=199.9 mg/dl, Non HDL-C= 168.0 mg/dl,
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Fenofibrate Monotherapy, WMER Niacin Monotherapy, Combination Therapy
Comments Multivariate Analysis of Covariance (MANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline Non HDL-C level as a covariate, with further adjustments for baseline TC and d-LDL-C.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.012
Comments Results were evaluated in terms of adjusted end line Non HDL-C levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.
Method MANCOVA
Comments Covariates appearing in MANCOVA model are evaluated at the following baseline values: Non HDL-C= 168.0 mg/dl,TC=199.9 mg/dl, d-LDL-C= 119.1 mg/dl.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Fenofibrate Monotherapy, WMER Niacin Monotherapy, Combination Therapy
Comments Multivariate Analysis of Covariance (MANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline RC level as a covariate, with further adjustments for baselineTC, Non HDL-C, d-LDL-C, and ApoB.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments Results were evaluated in terms of adjusted end line RC levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.
Method MANCOVA
Comments Covariates appearing in MANCOVA model are evaluated at the following baseline values:RC=48.9,TC=199.9, Non HDL-C=168.0, d-LDL-C=119.1, ApoB=133.1mg/dl
3.Primary Outcome
Title Changes in Serum Apolipoprotein Levels
Hide Description Assessments involve the measurement of serum Apolipoprotein A1 (Apo A1) and B (Apo B) levels.
Time Frame Treatments effects were assessed by two events, baseline investigations conducted before randomization and end line investigations at the end of the eighth week of treatments.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Fenofibrate Monotherapy WMER Niacin Monotherapy Combination Therapy
Hide Arm/Group Description:

Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch daily single placebo capsule for eight weeks.

Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.

Placebo

Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch 200mg daily single dose of fenofibrate (Lipanthyl® 200 mg micronized fenofibrate capsule, Abbott Laboratories Fournier) for eight weeks.

Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.

Fenofibrate

Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive a night-time 500 mg daily single dose of Wax Matrix Extended Release Niacin (WMER Niacin, ENDUR-ACIN®500mg, Endurance Products Company, Oregon USA) for one week, titrated up to 1000 mg by adding a daily morning-time ENDUR-ACIN®500mg tablet for the next seven weeks.

Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.

Wax Matrix Extended Release Niacin (WMER Niacin)

Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch 200mg daily single dose of fenofibrate for eight weeks, in combination with a night-time 500 mg daily single dose of WMER Niacin for one week, titrated up to 1000mg by adding a daily morning-time ENDUR-ACIN®500mg tablet for the next seven weeks.

Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.

Fenofibrate

Wax Matrix Extended Release Niacin (WMER Niacin)

Overall Number of Participants Analyzed 12 15 14 13
Mean (Standard Error)
Unit of Measure: mg/dl
Baseline Apo A1 130.8  (8.7) 143.8  (7.1) 150.1  (7.4) 150.0  (7.7)
Baseline Apo B 134.1  (7.5) 141.8  (6.1) 123.0  (6.3) 133.1  (6.6)
Adjusted End line Apo A1 130.2  (10.4) 155.9  (9.3) 134.2  (9.3) 162.3  (9.7)
Adjusted End line Apo B 124.7  (6.4) 106.7  (5.7) 111.1  (5.7) 101.7  (6.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Fenofibrate Monotherapy, WMER Niacin Monotherapy, Combination Therapy
Comments Multivariate Analysis of Covariance (MANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline ApoA1 level as a covariate, with further adjustments for baseline TG and HDL-C levels.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.058
Comments Results were evaluated in terms of adjusted end line ApoA1 levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.
Method MANCOVA
Comments Covariates appearing in MANCOVA model are evaluated at the following baseline values: ApoA1 = 144.6 mg/dl, TG= 240.4 mg/dl, HDL-C = 31.8 mg/dl.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Fenofibrate Monotherapy, WMER Niacin Monotherapy, Combination Therapy
Comments Multivariate Analysis of Covariance (MANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline ApoB level as a covariate, with further adjustments for baselineTC, Non HDL-C, dLDL-C, and RC .
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.067
Comments Results were evaluated in terms of adjusted end line ApoB levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.
Method MANCOVA
Comments Covariates appearing in MANCOVA model are evaluated at the following baseline values:ApoB=133.1, RC=48.9,TC=199.9, Non HDL-C=168.0, d-LDL-C=119.1mg/dl
4.Secondary Outcome
Title Changes in Serum Fasting Glucose Levels.
Hide Description Assessments involve the measurement of serum fasting glucose levels.
Time Frame Changes from baseline were assessed at the end eighth week of treatments.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Fenofibrate Monotherapy WMER Niacin Monotherapy Combination Therapy
Hide Arm/Group Description:

Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch daily single placebo capsule for eight weeks.

Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.

Placebo

Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch 200mg daily single dose of fenofibrate (Lipanthyl® 200 mg micronized fenofibrate capsule, Abbott Laboratories Fournier) for eight weeks.

Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.

Fenofibrate

Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive a night-time 500 mg daily single dose of Wax Matrix Extended Release Niacin (WMER Niacin, ENDUR-ACIN®500mg, Endurance Products Company, Oregon USA) for one week, titrated up to 1000 mg by adding a daily morning-time ENDUR-ACIN®500mg tablet for the next seven weeks.

Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.

Wax Matrix Extended Release Niacin (WMER Niacin)

Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch 200mg daily single dose of fenofibrate for eight weeks, in combination with a night-time 500 mg daily single dose of WMER Niacin for one week, titrated up to 1000mg by adding a daily morning-time ENDUR-ACIN®500mg tablet for the next seven weeks.

Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.

Fenofibrate

Wax Matrix Extended Release Niacin (WMER Niacin)

Overall Number of Participants Analyzed 12 15 14 13
Mean (Standard Error)
Unit of Measure: mg/dl
Baseline serum fasting glucose 93.5  (3.9) 98.9  (3.2) 94.6  (3.3) 94.7  (3.4)
Adjusted End line serum fasting glucose 91.3  (2.3) 91.7  (2.0) 100.1  (2.1) 87.3  (2.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Fenofibrate Monotherapy, WMER Niacin Monotherapy, Combination Therapy
Comments Analysis of Covariance (ANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline FSG level as a covariate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments Results were evaluated in terms of adjusted end line FSG levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.
Method ANCOVA
Comments Covariates appearing in ANCOVA model are evaluated at the following baseline values: FSG= 95.7 mg/dl.
5.Secondary Outcome
Title Changes in Estimated Glomerular Filtration Rate (eGFR)
Hide Description Assessments involve the measurement of serum creatinine which is used to calculate eGFR using the CKD-EPI equation (2009) .
Time Frame Changes from baseline were assessed at the end of the eighth week of treatments.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Fenofibrate Monotherapy WMER Niacin Monotherapy Combination Therapy
Hide Arm/Group Description:

Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch daily single placebo capsule for eight weeks.

Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.

Placebo

Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch 200mg daily single dose of fenofibrate (Lipanthyl® 200 mg micronized fenofibrate capsule, Abbott Laboratories Fournier) for eight weeks.

Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.

Fenofibrate

Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive a night-time 500 mg daily single dose of Wax Matrix Extended Release Niacin (WMER Niacin, ENDUR-ACIN®500mg, Endurance Products Company, Oregon USA) for one week, titrated up to 1000 mg by adding a daily morning-time ENDUR-ACIN®500mg tablet for the next seven weeks.

Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.

Wax Matrix Extended Release Niacin (WMER Niacin)

Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch 200mg daily single dose of fenofibrate for eight weeks, in combination with a night-time 500 mg daily single dose of WMER Niacin for one week, titrated up to 1000mg by adding a daily morning-time ENDUR-ACIN®500mg tablet for the next seven weeks.

Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.

Fenofibrate

Wax Matrix Extended Release Niacin (WMER Niacin)

Overall Number of Participants Analyzed 12 15 14 13
Mean (Standard Error)
Unit of Measure: ml/min per 1.73 m^2
Baseline eGFR 89.8  (4.8) 86.5  (3.9) 91.0  (4.1) 85.2  (4.2)
Adjusted End line eGFR 83.1  (3.4) 83.2  (3.1) 82.9  (3.2) 79.2  (3.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Fenofibrate Monotherapy, WMER Niacin Monotherapy, Combination Therapy
Comments Analysis of Covariance (ANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline eGFR level as a covariate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.786
Comments Results were evaluated in terms of adjusted end line eGFR levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.
Method ANCOVA
Comments Covariates appearing in ANCOVA model are evaluated at the following baseline values: eGFR= 88.0 ml/min per 1.73 m^2.
6.Secondary Outcome
Title Changes in Serum Uric Acid Levels
Hide Description Assessments involve the measurement of serum uric acid levels
Time Frame Changes from baseline were assessed at the end of the eighth week of treatments.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Fenofibrate Monotherapy WMER Niacin Monotherapy Combination Therapy
Hide Arm/Group Description:

Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch daily single placebo capsule for eight weeks.

Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.

Placebo

Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch 200mg daily single dose of fenofibrate (Lipanthyl® 200 mg micronized fenofibrate capsule, Abbott Laboratories Fournier) for eight weeks.

Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.

Fenofibrate

Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive a night-time 500 mg daily single dose of Wax Matrix Extended Release Niacin (WMER Niacin, ENDUR-ACIN®500mg, Endurance Products Company, Oregon USA) for one week, titrated up to 1000 mg by adding a daily morning-time ENDUR-ACIN®500mg tablet for the next seven weeks.

Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.

Wax Matrix Extended Release Niacin (WMER Niacin)

Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch 200mg daily single dose of fenofibrate for eight weeks, in combination with a night-time 500 mg daily single dose of WMER Niacin for one week, titrated up to 1000mg by adding a daily morning-time ENDUR-ACIN®500mg tablet for the next seven weeks.

Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.

Fenofibrate

Wax Matrix Extended Release Niacin (WMER Niacin)

Overall Number of Participants Analyzed 12 15 14 13
Mean (Standard Error)
Unit of Measure: mg/dl
Baseline serum uric acid 4.45  (0.30) 5.21  (0.24) 4.87  (0.25) 5.28  (0.26)
Adjusted End line serum uric acid 4.80  (0.25) 4.0  (0.22) 5.6  (0.23) 3.9  (0.24)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Fenofibrate Monotherapy, WMER Niacin Monotherapy, Combination Therapy
Comments Analysis of Covariance (ANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline serum uric acid level as a covariate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments Results were evaluated in terms of adjusted end line serum uric acid levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.
Method ANCOVA
Comments Covariates appearing in ANCOVA model are evaluated at the following baseline values: serum uric acid= 5.0 mg/dl.
7.Secondary Outcome
Title Changes in Serum Enzymes Levels
Hide Description Assessments involve the measurement of serum enzymes including Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Creatine Kinase (CK) levels.
Time Frame Changes from baseline were assessed at the end of the eighth week of treatments.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Fenofibrate Monotherapy WMER Niacin Monotherapy Combination Therapy
Hide Arm/Group Description:

Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch daily single placebo capsule for eight weeks.

Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.

Placebo

Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch 200mg daily single dose of fenofibrate (Lipanthyl® 200 mg micronized fenofibrate capsule, Abbott Laboratories Fournier) for eight weeks.

Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.

Fenofibrate

Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive a night-time 500 mg daily single dose of Wax Matrix Extended Release Niacin (WMER Niacin, ENDUR-ACIN®500mg, Endurance Products Company, Oregon USA) for one week, titrated up to 1000 mg by adding a daily morning-time ENDUR-ACIN®500mg tablet for the next seven weeks.

Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.

Wax Matrix Extended Release Niacin (WMER Niacin)

Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch 200mg daily single dose of fenofibrate for eight weeks, in combination with a night-time 500 mg daily single dose of WMER Niacin for one week, titrated up to 1000mg by adding a daily morning-time ENDUR-ACIN®500mg tablet for the next seven weeks.

Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.

Fenofibrate

Wax Matrix Extended Release Niacin (WMER Niacin)

Overall Number of Participants Analyzed 12 15 14 13
Mean (Standard Error)
Unit of Measure: IU/L
Baseline AST 17.1  (1.6) 18.8  (1.3) 17.0  (1.4) 18.9  (1.4)
Baseline ALT 13.1  (1.4) 16.3  (1.2) 16.0  (1.2) 17.8  (1.2)
Baseline CK 28.0  (4.7) 29.1  (3.8) 26.9  (4.0) 28.0  (4.1)
Adjusted End line AST 18.9  (0.8) 17.3  (0.8) 18.0  (0.8) 19.6  (0.8)
Adjusted End line ALT 15.4  (0.6) 14.4  (0.5) 16.4  (0.5) 16.2  (0.6)
Adjusted End line CK 27.3  (4.7) 34.9  (4.2) 27.4  (4.4) 28.2  (4.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Fenofibrate Monotherapy, WMER Niacin Monotherapy, Combination Therapy
Comments Analysis of Covariance (ANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline AST level as a covariate.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.201
Comments Results were evaluated in terms of adjusted end line AST levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.
Method ANCOVA
Comments

Covariates appearing in ANCOVA model are evaluated at the following baseline values: AST= 18.1 IU/L.

.

Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Fenofibrate Monotherapy, WMER Niacin Monotherapy, Combination Therapy
Comments Analysis of Covariance (ANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline ALT level as a covariate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.033
Comments Results were evaluated in terms of adjusted end line ALT levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.
Method ANCOVA
Comments Covariates appearing in ANCOVA model are evaluated at the following baseline values: ALT= 16.0 IU/L.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Fenofibrate Monotherapy, WMER Niacin Monotherapy, Combination Therapy
Comments Analysis of Covariance (ANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline CK level as a covariate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.511
Comments Results were evaluated in terms of adjusted end line CK levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.
Method ANCOVA
Comments Covariates appearing in ANCOVA model are evaluated at the following baseline values: CK= 28.0 IU/L.
8.Secondary Outcome
Title Changes in Systolic and Diastolic Blood Pressure
Hide Description Assessments involve the measurement of systolic and diastolic blood pressure. Patients were allowed to rest for 15 minutes in sitting position, and Walgreens Homedics WGNBPA-540 upper arm blood pressure monitor (Walgreens, China), was used for the measurement of blood pressure. Three consecutive readings were taken at 1 minute interval, and systolic and diastolic blood pressure were calculated as the mean of the last two readings.
Time Frame Changes from baseline were assessed at the end of the eighth week of treatments.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Fenofibrate Monotherapy WMER Niacin Monotherapy Combination Therapy
Hide Arm/Group Description:

Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch daily single placebo capsule for eight weeks.

Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.

Placebo

Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch 200mg daily single dose of fenofibrate (Lipanthyl® 200 mg micronized fenofibrate capsule, Abbott Laboratories Fournier) for eight weeks.

Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.

Fenofibrate

Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive a night-time 500 mg daily single dose of Wax Matrix Extended Release Niacin (WMER Niacin, ENDUR-ACIN®500mg, Endurance Products Company, Oregon USA) for one week, titrated up to 1000 mg by adding a daily morning-time ENDUR-ACIN®500mg tablet for the next seven weeks.

Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.

Wax Matrix Extended Release Niacin (WMER Niacin)

Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch 200mg daily single dose of fenofibrate for eight weeks, in combination with a night-time 500 mg daily single dose of WMER Niacin for one week, titrated up to 1000mg by adding a daily morning-time ENDUR-ACIN®500mg tablet for the next seven weeks.

Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.

Fenofibrate

Wax Matrix Extended Release Niacin (WMER Niacin)

Overall Number of Participants Analyzed 12 15 14 13
Mean (Standard Error)
Unit of Measure: mmHg
Baseline diastolic blood pressure 80.7  (2.6) 83.5  (2.1) 76.1  (2.3) 77.3  (2.4)
Baseline systolic blood pressure 120.7  (3.9) 125.4  (3.1) 118.5  (3.4) 119.5  (3.5)
Adjusted End line diastolic blood pressure 79.5  (1.0) 78.6  (0.9) 80.3  (1.1) 80.9  (1.1)
Adjusted End line systolic blood pressure 118.3  (2.1) 117.4  (1.8) 117.8  (2.2) 118.8  (2.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Fenofibrate Monotherapy, WMER Niacin Monotherapy, Combination Therapy
Comments Analysis of Covariance (ANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline diastolic blood pressure level as a covariate.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.434
Comments Results were evaluated in terms of adjusted end line diastolic blood pressure levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.
Method ANCOVA
Comments Covariates appearing in ANCOVA model are evaluated at the following baseline values: diastolic blood pressure= 80.0 mmHg.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Fenofibrate Monotherapy, WMER Niacin Monotherapy, Combination Therapy
Comments Analysis of Covariance (ANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline systolic blood pressure level as a covariate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.966
Comments Results were evaluated in terms of adjusted end line systolic blood pressure levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.
Method ANCOVA
Comments Covariates appearing in ANCOVA model are evaluated at the following baseline values: systolic blood pressure= 121.5 mmHg.
9.Secondary Outcome
Title Adverse Events
Hide Description

Assessments comprise the total number of participants complicating and reporting muscle pain,flushing, nausea, vomiting, and dizziness.

As part of the complete safety profile of each arm,other specific reported adverse event are presented in the Adverse Event Module.

Time Frame Changes from baseline were assessed at the end of the eighth week of treatments.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Fenofibrate Monotherapy WMER Niacin Monotherapy Combination Therapy
Hide Arm/Group Description:

Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch daily single placebo capsule for eight weeks.

Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.

Placebo

Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch 200mg daily single dose of fenofibrate (Lipanthyl® 200 mg micronized fenofibrate capsule, Abbott Laboratories Fournier) for eight weeks.

Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.

Fenofibrate

Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive a night-time 500 mg daily single dose of Wax Matrix Extended Release Niacin (WMER Niacin, ENDUR-ACIN®500mg, Endurance Products Company, Oregon USA) for one week, titrated up to 1000 mg by adding a daily morning-time ENDUR-ACIN®500mg tablet for the next seven weeks.

Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.

Wax Matrix Extended Release Niacin (WMER Niacin)

Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch 200mg daily single dose of fenofibrate for eight weeks, in combination with a night-time 500 mg daily single dose of WMER Niacin for one week, titrated up to 1000mg by adding a daily morning-time ENDUR-ACIN®500mg tablet for the next seven weeks.

Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.

Fenofibrate

Wax Matrix Extended Release Niacin (WMER Niacin)

Overall Number of Participants Analyzed 12 15 14 13
Measure Type: Count of Participants
Unit of Measure: Participants
Muscle Pain
0
   0.0%
0
   0.0%
0
   0.0%
1
   7.7%
Flushing
0
   0.0%
0
   0.0%
1
   7.1%
0
   0.0%
Nausea/Vomiting
0
   0.0%
0
   0.0%
3
  21.4%
1
   7.7%
Dizziness
0
   0.0%
0
   0.0%
0
   0.0%
1
   7.7%
Time Frame Up to the end of the eighth week of treatments.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Fenofibrate Monotherapy WMER Niacin Monotherapy Combination Therapy
Hide Arm/Group Description

Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch daily single placebo capsule for eight weeks.

Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.

Placebo

Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch 200mg daily single dose of fenofibrate (Lipanthyl® 200 mg micronized fenofibrate capsule, Abbott Laboratories Fournier) for eight weeks.

Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.

Fenofibrate

Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive a night-time 500 mg daily single dose of Wax Matrix Extended Release Niacin (WMER Niacin, ENDUR-ACIN®500mg, Endurance Products Company, Oregon USA) for one week, titrated up to 1000 mg by adding a daily morning-time ENDUR-ACIN®500mg tablet for the next seven weeks.

Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.

Wax Matrix Extended Release Niacin (WMER Niacin)

Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch 200mg daily single dose of fenofibrate for eight weeks, in combination with a night-time 500 mg daily single dose of WMER Niacin for one week, titrated up to 1000mg by adding a daily morning-time ENDUR-ACIN®500mg tablet for the next seven weeks.

Therapeutic Lifestyle Changes: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.

Fenofibrate

Wax Matrix Extended Release Niacin (WMER Niacin)

All-Cause Mortality
Placebo Fenofibrate Monotherapy WMER Niacin Monotherapy Combination Therapy
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/15 (0.00%)   0/14 (0.00%)   0/13 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Fenofibrate Monotherapy WMER Niacin Monotherapy Combination Therapy
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/15 (0.00%)   0/14 (0.00%)   0/13 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Fenofibrate Monotherapy WMER Niacin Monotherapy Combination Therapy
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/15 (0.00%)   7/14 (50.00%)   3/13 (23.08%) 
Gastrointestinal disorders         
Nausea/Vomiting   0/12 (0.00%)  0/15 (0.00%)  3/14 (21.43%)  1/13 (7.69%) 
General disorders         
Flushing   0/12 (0.00%)  0/15 (0.00%)  1/14 (7.14%)  0/13 (0.00%) 
Hepatobiliary disorders         
ALT or AST >3ULN   0/12 (0.00%)  0/15 (0.00%)  0/14 (0.00%)  0/13 (0.00%) 
Metabolism and nutrition disorders         
Uric acid > 6 mg/dl   0/12 (0.00%)  0/15 (0.00%)  3/14 (21.43%)  0/13 (0.00%) 
Musculoskeletal and connective tissue disorders         
Muscle Pain   0/12 (0.00%)  0/15 (0.00%)  0/14 (0.00%)  1/13 (7.69%) 
Nervous system disorders         
Dizziness   0/12 (0.00%)  0/15 (0.00%)  0/14 (0.00%)  1/13 (7.69%) 
Renal and urinary disorders         
eGFR˂ 60ml/min per 1.73 m^2   0/12 (0.00%)  0/15 (0.00%)  0/14 (0.00%)  0/13 (0.00%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Lewai Sharki Abdulaziz
Organization: Al-Kindy College of Medicine, ////university of Baghdad
Phone: 750 659 0024 ext +964
EMail: lewaisharki@kmc.uobaghdad.edu.iq
Layout table for additonal information
Responsible Party: Lewai Sharki Abdulaziz, MSc PhD, Al-Kindy College of Medicine
ClinicalTrials.gov Identifier: NCT03615534     History of Changes
Other Study ID Numbers: 1Al-KindyCM
First Submitted: July 27, 2018
First Posted: August 6, 2018
Results First Submitted: August 4, 2018
Results First Posted: October 12, 2018
Last Update Posted: September 4, 2019