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12-Month, Open-Label, Extension Study of LCP-AtorFen in Dyslipidemia

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ClinicalTrials.gov Identifier: NCT00664859
Recruitment Status : Completed
First Posted : April 23, 2008
Results First Posted : March 24, 2020
Last Update Posted : March 24, 2020
Sponsor:
Information provided by (Responsible Party):
Veloxis Pharmaceuticals

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Dyslipidemia
Intervention Drug: LCP-AtorFen
Enrollment 140
Recruitment Details Of the 192 subjects who completed the double-blind (DB) period, 140 rolled over into the extension study and received at least one dose of open-label (OL) study drug to form the safety population.
Pre-assignment Details  
Arm/Group Title LCP-AtorFen 40/100 mg Atorvastatin 40 mg Fenofibrate 145 mg
Hide Arm/Group Description Subjects randomized to LCP-AtorFen 40/100 mg/day in the DB portion of the study Subjects randomized to Atorvastatin 40 mg/day in the DB portion of the study Subjects randomized to Fenofibrate 145 mg/day in the DB portion of the study
Period Title: Overall Study
Started 51 45 44
Completed 34 35 23
Not Completed 17 10 21
Reason Not Completed
Adverse Event             2             1             3
DB Study (LCP-AtorFen-2001) AE             6             4             4
Noncompliance with protocol             1             0             4
Laboratory abnormality             2             1             4
Withdrawal by Subject             4             1             3
Lost to Follow-up             2             2             1
Other             0             1             2
Arm/Group Title LCP-AtorFen 40/100mg Atorvastatin 40 mg Fenofibrate 145 mg Total
Hide Arm/Group Description Data presented by previous double-blind study assignment Data presented by previous double-blind study assignment Data presented by previous double-blind study assignment Total of all reporting groups
Overall Number of Baseline Participants 51 45 44 140
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 51 participants 45 participants 44 participants 140 participants
54.6  (10.86) 55.6  (9.03) 57.2  (11.23) 55.7  (10.41)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants 45 participants 44 participants 140 participants
Female
18
  35.3%
20
  44.4%
17
  38.6%
55
  39.3%
Male
33
  64.7%
25
  55.6%
27
  61.4%
85
  60.7%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants 45 participants 44 participants 140 participants
Hispanic or Latino
2
   3.9%
4
   8.9%
1
   2.3%
7
   5.0%
Amer. Indian /Alaskan
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black/African
3
   5.9%
3
   6.7%
1
   2.3%
7
   5.0%
Hawaiian/Other
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White
46
  90.2%
38
  84.4%
42
  95.5%
126
  90.0%
1.Primary Outcome
Title Change in Non-HDL Cholesterol, HDL Cholesterol, TG Levels From Baseline to End of Treatment
Hide Description Mean percent changes in non-HDL cholesterol, HDL cholesterol, TG levels from the double-blind (DB) baseline (Week 0) to end-of-treatment (Week 52), and from the open-label (OL) baseline (week 12 of DB study) to end of treatment (Week 52)
Time Frame 52 weeks from DB baseline and 40 weeks from OL baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent-to-treat population
Arm/Group Title LCP-AtorFen 40/100mg Atorvastatin 40 mg Fenofibrate 145 mg
Hide Arm/Group Description:
Data presented by previous double-blind study assignment
Data presented by previous double-blind study assignment
Data presented by previous double-blind study assignment
Overall Number of Participants Analyzed 51 44 43
Mean (Standard Deviation)
Unit of Measure: percent change
Non-HDL cholesterol, change from DB baseline -48.2  (13.58) -43.6  (18.18) -42.0  (20.49)
Non-HDL cholesterol change from OL baseline 2.6  (22.39) 2.8  (33.67) -29.6  (26.92)
Triglycerides change from DB baseline -53.1  (25.31) -51.2  (23.23) -42.1  (29.96)
Triglycerides change from OL baseline 11.4  (65.36) -19.1  (40.42) -5.2  (53.27)
HDL cholesterol change from DB baseline 22.1  (21.7) 16.3  (18.67) 17.5  (20.21)
HDL cholesterol change from OL baseline 2.1  (16.9) 10.1  (17.77) -2.4  (15.4)
2.Secondary Outcome
Title Change in LDL Cholesterol, VLDL, Total Cholesterol, Apo A-1, and Apo B From Baseline to End of Treatment
Hide Description Mean percent changes in LDL cholesterol, VLDL, total cholesterol, Apo A-1, and Apo B from the double-blind (DB) baseline (Week 0) to end-of-treatment (Week 52), and from the open-label (OL) baseline (week 12) to end-of-treatment (Week 52)
Time Frame 52 weeks from DB baseline and 40 weeks from OL baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title LCP-AtorFen 40/100mg Atorvastatin 40 mg Fenofibrate 145 mg
Hide Arm/Group Description:
Data presented by previous double-blind study assignment
Data presented by previous double-blind study assignment
Data presented by previous double-blind study assignment
Overall Number of Participants Analyzed 51 44 43
Mean (Standard Deviation)
Unit of Measure: Percent change
LDL-C change from DB baseline -44.8  (15.92) -39.3  (20.04) -40.9  (22.0)
LDL-C change from OL baseline 2.1  (25.09) 14  (36.29) -33.6  (24.26)
VLDL-C change from DB baseline -53.6  (23.98) -51.1  (23.07) -42.0  (29.94)
VLDL-C change from OL baseline 12.7  (69.42) -18.7  (39.97) -5.5  (51.98)
Total-C change from DB baseline -36.5  (11.07) -33.8  (14.6) -32.8  (16.08)
Total-C change from OL baseline 1.5  (12.95) 4.6  (24.54) -24.4  (19.04)
Apo A-1 change from DB baseline 3.2  (13.21) 1.0  (9.88) 0.4  (12.5)
Apo-A-1 change from OL baseline -1.4  (8.11) 1.9  (13.62) -5.1  (11.36)
Apo B change from DB baseline -42.4  (11.85) -38.9  (16.26) -36.8  (18.81)
Apo B change from OL baseline 3.1  (17.69) -1.5  (25.14) -25.5  (21.59)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title LCP-AtorFen 40/100mg Atorvastatin 40 mg Fenofibrate 145 mg
Hide Arm/Group Description Data presented by previous double-blind study assignment Data presented by previous double-blind study assignment Data presented by previous double-blind study assignment
All-Cause Mortality
LCP-AtorFen 40/100mg Atorvastatin 40 mg Fenofibrate 145 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/51 (0.00%)   0/45 (0.00%)   0/44 (0.00%) 
Hide Serious Adverse Events
LCP-AtorFen 40/100mg Atorvastatin 40 mg Fenofibrate 145 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/51 (5.88%)   1/45 (2.22%)   3/44 (6.82%) 
Gastrointestinal disorders       
Appendicitis *  0/51 (0.00%)  0/45 (0.00%)  1/44 (2.27%) 
Injury, poisoning and procedural complications       
Fracture treatment *  1/51 (1.96%)  0/45 (0.00%)  0/44 (0.00%) 
Investigations       
Elevated ALT *  0/51 (0.00%)  0/45 (0.00%)  1/44 (2.27%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Prostate cancer *  1/51 (1.96%)  0/45 (0.00%)  0/44 (0.00%) 
Rectal cancer metastatic *  1/51 (1.96%)  0/45 (0.00%)  0/44 (0.00%) 
Colon cancer *  0/51 (0.00%)  0/45 (0.00%)  1/44 (2.27%) 
Breast cancer *  0/51 (0.00%)  1/45 (2.22%)  0/44 (0.00%) 
Vascular disorders       
Deep vein thrombosis *  0/51 (0.00%)  0/45 (0.00%)  1/44 (2.27%) 
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
LCP-AtorFen 40/100mg Atorvastatin 40 mg Fenofibrate 145 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   12/51 (23.53%)   21/45 (46.67%)   21/44 (47.73%) 
Endocrine disorders       
Blood glucose increased *  1/51 (1.96%)  1/45 (2.22%)  4/44 (9.09%) 
Gastrointestinal disorders       
Diarrhoea *  1/51 (1.96%)  6/45 (13.33%)  1/44 (2.27%) 
Infections and infestations       
Nasopharyngitis *  6/51 (11.76%)  9/45 (20.00%)  9/44 (20.45%) 
Upper respiratory tract infection *  3/51 (5.88%)  6/45 (13.33%)  4/44 (9.09%) 
Musculoskeletal and connective tissue disorders       
Muscle spasms *  1/51 (1.96%)  2/45 (4.44%)  3/44 (6.82%) 
Renal and urinary disorders       
Haematuria *  0/51 (0.00%)  3/45 (6.67%)  0/44 (0.00%) 
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The study is a multicenter collaborative investigation and the clinical trial results are to be published as a collaborative manuscript. Authorship will reflect varying levels of individual contribution to the study by the individual PI's.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director, Regulatory Affairs
Organization: Veloxis Pharmaceuticals, Inc.
Phone: 919-591-3090
EMail: bbu@veloxis.com
Layout table for additonal information
Responsible Party: Veloxis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00664859    
Other Study ID Numbers: LCP-AtorFen-2001-1X
First Submitted: April 21, 2008
First Posted: April 23, 2008
Results First Submitted: February 14, 2020
Results First Posted: March 24, 2020
Last Update Posted: March 24, 2020