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Trial record 46 of 73 for:    HYDROCHLOROTHIAZIDE AND LOSARTAN

SAALT: Subtracting Salt and Adding Losartan Trial (0954A-335)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00739674
Recruitment Status : Completed
First Posted : August 22, 2008
Results First Posted : August 11, 2010
Last Update Posted : May 5, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hypertension
Interventions Drug: losartan potassium (+ hydrochlorothiazide [HCTZ] + calcium channel blocker [CCB])
Behavioral: Low Salt Diet
Enrollment 992
Recruitment Details

First patient in: FEB-05-2008

Last patient out: JAN-15-2010

Total number of sites: 109 sites in Canada

Pre-assignment Details  
Arm/Group Title Losartan-Based Regimen Alone (L Group) Diet Management and Losartan-Based Regimen (DML Group)
Hide Arm/Group Description Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including hydrochlorothiazide (HCTZ) 12.5 mg or 25 mg and calcium channel blocker (CCB) as needed to achieve target blood pressure. Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure combined with low-salt Dietary Approaches to Stop Hypertension (DASH) diet management.
Period Title: Overall Study
Started 535 457
Screening Failures 19 17 [1]
Site 212 Removal 19 [2] 13 [2]
No Follow-up Data 33 18
Dietician Consultation >30 Days 1 [3] 9 [3]
Intent-to-treat (ITT) Population 463 [1] 400 [1]
Completed 354 335
Not Completed 181 122
Reason Not Completed
Screening failures             19             17
Site 212 removal             19             13
No follow-up data             33             18
Dietician consultation >30 days             1             9
Adverse Event             22             13
Death             1             0
Lack of Efficacy             1             0
Lost to Follow-up             52             30
Protocol Violation             5             5
Withdrawal by Subject             9             9
Reason missing             2             0
Clinic closed             6             4
Patient moved             3             2
Non compliant             4             0
Unable to attend visit             3             1
Home monitoring off meds             1             0
Erectile dysfunction             0             1
[1]
ITT population took at least one dose of the study medication and had one follow-up visit.
[2]
lack of source documentation & frequent discrepancies between source notes and case report entries.
[3]
Patients with dietician consultations >30 days after visit 1 were not included in the data analysis.
Arm/Group Title Losartan-Based Regimen Alone (L Group) Diet Management and Losartan-Based Regimen (DML Group) Total
Hide Arm/Group Description

Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure.

The Baseline Measures are reported for the Intent-to-treat (ITT) population (i.e. took at least one dose of the study medication and returned for one follow-up visit).

Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure combined with low-salt DASH diet management.

The Baseline Measures are reported for the Intent-to-treat (ITT) population (i.e. took at least one dose of the study medication and returned for one follow-up visit).

Total of all reporting groups
Overall Number of Baseline Participants 463 400 863
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 463 participants 400 participants 863 participants
56.05  (11.54) 54.59  (11.98) 55.38  (11.76)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 463 participants 400 participants 863 participants
Female
239
  51.6%
208
  52.0%
447
  51.8%
Male
224
  48.4%
192
  48.0%
416
  48.2%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 463 participants 400 participants 863 participants
White 404 369 773
Black 9 4 13
Hispanic 2 1 3
Asian 38 20 58
Native Indian 3 2 5
Other 7 4 11
Cardiovascular Risk   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 463 participants 400 participants 863 participants
High 112 92 204
Medium 94 61 155
Low 218 216 434
Not Available 35 27 62
Missing 4 4 8
[1]
Measure Description: Cardiovascular Risk according to Framingham Equation
Diastolic Blood Pressure  
Mean (Standard Deviation)
Unit of measure:  Mm Hg
Number Analyzed 463 participants 400 participants 863 participants
90.67  (9.19) 91.43  (9.98) 91.02  (9.57)
Systolic Blood Pressure  
Mean (Standard Deviation)
Unit of measure:  Mm Hg
Number Analyzed 463 participants 400 participants 863 participants
151.23  (10.80) 151.11  (12.55) 151.17  (11.64)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilograms
Number Analyzed 463 participants 400 participants 863 participants
85.41  (19.95) 89.17  (20.18) 87.16  (20.13)
1.Primary Outcome
Title Number of Patients Achieving Target Blood Pressure at Week 14 From Baseline
Hide Description Number of Patients Achieving Target Blood Pressure (<140/90 mm Hg and <130/80 mm Hg for diabetics) from baseline after 14 weeks of treatment
Time Frame 14 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
463 and 400 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 392 and 357 patients at week 14 for L group and DML group respectively.
Arm/Group Title Losartan-Based Regimen Alone (L Group) Diet Management and Losartan-Based Regimen (DML Group)
Hide Arm/Group Description:
Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure.
Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure combined with low-salt DASH diet management.
Overall Number of Participants Analyzed 392 357
Measure Type: Number
Unit of Measure: Participants
Achieve Target Blood Pressure 276 270
Did not Achieve Target Blood Pressure 116 87
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Losartan-Based Regimen Alone (L Group), Diet Management and Losartan-Based Regimen (DML Group)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.118
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
2.Primary Outcome
Title Change in Systolic Blood Pressure From Baseline to Week 14
Hide Description [Not Specified]
Time Frame 14 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
463 and 400 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 392 and 357 patients at week 14 for L group and DML group respectively.
Arm/Group Title Losartan-Based Regimen Alone (L Group) Diet Management and Losartan-Based Regimen (DML Group)
Hide Arm/Group Description:
Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure.
Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure combined with low-salt DASH diet management.
Overall Number of Participants Analyzed 392 357
Mean (Standard Deviation)
Unit of Measure: mm Hg
-21.01  (14.11) -22.74  (15.81)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Losartan-Based Regimen Alone (L Group), Diet Management and Losartan-Based Regimen (DML Group)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.507
Comments [Not Specified]
Method Regression, Linear
Comments Adjusted for study medication, age, gender, race, cardiovascular risk, baseline weight, and baseline waist circumference.
3.Primary Outcome
Title Change in Diastolic Blood Pressure From Baseline to Week 14
Hide Description [Not Specified]
Time Frame 14 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
463 and 400 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 392 and 357 patients at week 14 for L group and DML group respectively.
Arm/Group Title Losartan-Based Regimen Alone (L Group) Diet Management and Losartan-Based Regimen (DML Group)
Hide Arm/Group Description:
Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure.
Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure combined with low-salt DASH diet management.
Overall Number of Participants Analyzed 392 357
Mean (Standard Deviation)
Unit of Measure: mm Hg
-10.19  (9.33) -12.05  (9.50)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Losartan-Based Regimen Alone (L Group), Diet Management and Losartan-Based Regimen (DML Group)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.058
Comments [Not Specified]
Method Regression, Linear
Comments Adjusted for study medication, age, gender, race, cardiovascular risk, baseline weight, and baseline waist circumference.
4.Secondary Outcome
Title Number of Patients Achieving Target Blood Pressure at Week 6 From Baseline
Hide Description Number of Patients Achieving Target Blood Pressure (<140/90 mm Hg and <130/80 mm Hg for diabetics) from baseline after 6 weeks of treatment
Time Frame 6 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
463 and 400 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 431 and 383 patients at week 6 for L group and DML group respectively.
Arm/Group Title Losartan-Based Regimen Alone (L Group) Diet Management and Losartan-Based Regimen (DML Group)
Hide Arm/Group Description:
Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure.
Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure combined with low-salt DASH diet management.
Overall Number of Participants Analyzed 431 383
Measure Type: Number
Unit of Measure: Participants
Achieve Target Blood Pressure 239 231
Did not Achieve Target Blood Pressure 192 152
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Losartan-Based Regimen Alone (L Group), Diet Management and Losartan-Based Regimen (DML Group)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.092
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
5.Secondary Outcome
Title Number of Patients Achieving Target Blood Pressure at Week 10 From Baseline
Hide Description Number of Patients Achieving Target Blood Pressure (<140/90 mm Hg and <130/80 mm Hg for diabetics) from baseline after 10 weeks of treatment
Time Frame 10 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
463 and 400 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 399 and 370 patients at week 10 for L group and DML group respectively.
Arm/Group Title Losartan-Based Regimen Alone (L Group) Diet Management and Losartan-Based Regimen (DML Group)
Hide Arm/Group Description:
Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure.
Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure combined with low-salt DASH diet management.
Overall Number of Participants Analyzed 399 370
Measure Type: Number
Unit of Measure: Participants
Achieve Target Blood Pressure 257 254
Did not Achieve Target Blood Pressure 142 116
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Losartan-Based Regimen Alone (L Group), Diet Management and Losartan-Based Regimen (DML Group)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.122
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
6.Secondary Outcome
Title Number of Patients Achieving Target Blood Pressure at Week 40 From Baseline
Hide Description Number of Patients Achieving Target Blood Pressure (<140/90 mm Hg and <130/80 mm Hg for diabetics) from baseline after 40 weeks of treatment
Time Frame 40 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
463 and 400 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 351 and 331 patients at week 40 for L group and DML group respectively.
Arm/Group Title Losartan-Based Regimen Alone (L Group) Diet Management and Losartan-Based Regimen (DML Group)
Hide Arm/Group Description:
Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure.
Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure combined with low-salt DASH diet management.
Overall Number of Participants Analyzed 351 331
Measure Type: Number
Unit of Measure: Participants
Achieve Target Blood Pressure 264 240
Did not Achieve Target Blood Pressure 87 91
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Losartan-Based Regimen Alone (L Group), Diet Management and Losartan-Based Regimen (DML Group)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.434
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
7.Secondary Outcome
Title Change in Systolic Blood Pressure From Baseline to Week 6
Hide Description [Not Specified]
Time Frame 6 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
463 and 400 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 431 and 383 patients at week 6 for L group and DML group respectively.
Arm/Group Title Losartan-Based Regimen Alone (L Group) Diet Management and Losartan-Based Regimen (DML Group)
Hide Arm/Group Description:
Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure.
Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure combined with low-salt DASH diet management.
Overall Number of Participants Analyzed 431 383
Mean (Standard Deviation)
Unit of Measure: mm Hg
-16.81  (14.92) -18.85  (16.18)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Losartan-Based Regimen Alone (L Group), Diet Management and Losartan-Based Regimen (DML Group)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.158
Comments [Not Specified]
Method Regression, Linear
Comments Adjusted for study medication, age, gender, race, cardiovascular risk, baseline weight, and baseline waist circumference.
8.Secondary Outcome
Title Change in Diastolic Blood Pressure From Baseline to Week 6
Hide Description [Not Specified]
Time Frame 6 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
463 and 400 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 431 and 383 patients at week 6 for L group and DML group respectively.
Arm/Group Title Losartan-Based Regimen Alone (L Group) Diet Management and Losartan-Based Regimen (DML Group)
Hide Arm/Group Description:
Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure.
Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure combined with low-salt DASH diet management.
Overall Number of Participants Analyzed 431 383
Mean (Standard Deviation)
Unit of Measure: mm Hg
-8.34  (9.29) -9.76  (9.82)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Losartan-Based Regimen Alone (L Group), Diet Management and Losartan-Based Regimen (DML Group)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.064
Comments [Not Specified]
Method Regression, Linear
Comments Adjusted for study medication, age, gender, race, cardiovascular risk, baseline weight, and baseline waist circumference.
9.Secondary Outcome
Title Change in Systolic Blood Pressure From Baseline to Week 10
Hide Description [Not Specified]
Time Frame 10 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
463 and 400 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 399 and 370 patients at week 10 for L group and DML group respectively.
Arm/Group Title Losartan-Based Regimen Alone (L Group) Diet Management and Losartan-Based Regimen (DML Group)
Hide Arm/Group Description:
Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure.
Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure combined with low-salt DASH diet management.
Overall Number of Participants Analyzed 399 370
Mean (Standard Deviation)
Unit of Measure: mm Hg
-19.11  (14.87) -20.95  (16.24)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Losartan-Based Regimen Alone (L Group), Diet Management and Losartan-Based Regimen (DML Group)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.262
Comments [Not Specified]
Method Regression, Linear
Comments Adjusted for study medication, age, gender, race, cardiovascular risk, baseline weight, and baseline waist circumference.
10.Secondary Outcome
Title Change in Diastolic Blood Pressure From Baseline to Week 10
Hide Description [Not Specified]
Time Frame 10 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
463 and 400 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 399 and 370 patients at week 10 for L group and DML group respectively.
Arm/Group Title Losartan-Based Regimen Alone (L Group) Diet Management and Losartan-Based Regimen (DML Group)
Hide Arm/Group Description:
Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure.
Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure combined with low-salt DASH diet management.
Overall Number of Participants Analyzed 399 370
Mean (Standard Deviation)
Unit of Measure: mm Hg
-9.48  (8.80) -11.42  (9.45)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Losartan-Based Regimen Alone (L Group), Diet Management and Losartan-Based Regimen (DML Group)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.026
Comments [Not Specified]
Method Regression, Linear
Comments Adjusted for study medication, age, gender, race, cardiovascular risk, baseline weight, and baseline waist circumference.
11.Secondary Outcome
Title Time to Achieve the Target Blood Pressure From Baseline
Hide Description Time to achieve the target blood pressure (<140/90 mm Hg and <130/80 mm Hg for diabetics).
Time Frame 14 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
463 and 400 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 437 and 386 patients for L group and DML group respectively.
Arm/Group Title Losartan-Based Regimen Alone (L Group) Diet Management and Losartan-Based Regimen (DML Group)
Hide Arm/Group Description:
Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure.
Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure combined with low-salt DASH diet management.
Overall Number of Participants Analyzed 437 386
Median (95% Confidence Interval)
Unit of Measure: Weeks
7.43
(6.24 to 8.62)
6.57
(6.29 to 6.85)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Losartan-Based Regimen Alone (L Group), Diet Management and Losartan-Based Regimen (DML Group)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.212
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description A total of 8 patients were removed from the safety population because they did not receive at least one dose of the study medication. Therefore, the safety population was based on 984 patients (531 in the L Group and 453 in the DML Group) of the total 992 enrolled patients.
 
Arm/Group Title Losartan-Based Regimen Alone (L Group) Diet Management and Losartan-Based Regimen (DML Group)
Hide Arm/Group Description Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure. Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure combined with low-salt DASH diet management.
All-Cause Mortality
Losartan-Based Regimen Alone (L Group) Diet Management and Losartan-Based Regimen (DML Group)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Losartan-Based Regimen Alone (L Group) Diet Management and Losartan-Based Regimen (DML Group)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   13/531 (2.45%)      10/453 (2.21%)    
Cardiac disorders     
Acute myocardial infarction  1  0/531 (0.00%)  2/453 (0.44%)  2
Atrial fibrillation  1  1/531 (0.19%)  1 0/453 (0.00%) 
Cardiac failure congestive  1  1/531 (0.19%)  1 0/453 (0.00%) 
Cardio-respiratory arrest  1  1/531 (0.19%)  1 0/453 (0.00%) 
Myocardial infarction  1  0/531 (0.00%)  2/453 (0.44%)  2
Palpitations  1  0/531 (0.00%)  1/453 (0.22%)  1
Supraventricular tachycardia  1  0/531 (0.00%)  1/453 (0.22%)  1
Tachycardia  1  0/531 (0.00%)  1/453 (0.22%)  1
Gastrointestinal disorders     
Dry mouth  1  0/531 (0.00%)  1/453 (0.22%)  1
Oesophagitis  1  1/531 (0.19%)  1 0/453 (0.00%) 
Pancreatitis acute  1  1/531 (0.19%)  1 0/453 (0.00%) 
General disorders     
Inflammation  1  0/531 (0.00%)  1/453 (0.22%)  1
Immune system disorders     
Amyloidosis  1  0/531 (0.00%)  1/453 (0.22%)  1
Infections and infestations     
Appendicitis  1  1/531 (0.19%)  1 0/453 (0.00%) 
Diverticulitis  1  1/531 (0.19%)  1 0/453 (0.00%) 
Gastroenteritis  1  0/531 (0.00%)  1/453 (0.22%)  1
Pneumonia  1  0/531 (0.00%)  1/453 (0.22%)  1
Injury, poisoning and procedural complications     
Pseudocyst  1  1/531 (0.19%)  1 0/453 (0.00%) 
Investigations     
Blood creatine phosphokinase increased  1  0/531 (0.00%)  1/453 (0.22%)  1
Red blood cell sedimentation rate increased  1  0/531 (0.00%)  1/453 (0.22%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Colon cancer  1  0/531 (0.00%)  1/453 (0.22%)  1
Metastases to bladder  1  1/531 (0.19%)  1 0/453 (0.00%) 
Multiple myeloma  1  0/531 (0.00%)  1/453 (0.22%)  1
Prostate cancer metastatic  1  1/531 (0.19%)  1 0/453 (0.00%) 
Nervous system disorders     
Haemorrhagic stroke  1  1/531 (0.19%)  1 0/453 (0.00%) 
Transient ischaemic attack  1  1/531 (0.19%)  1 0/453 (0.00%) 
Renal and urinary disorders     
Nephrolithiasis  1  1/531 (0.19%)  1 0/0 
Renal failure acute  1  0/531 (0.00%)  1/453 (0.22%)  1
Reproductive system and breast disorders     
Epididymitis  1  1/531 (0.19%)  1 0/453 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Respiratory failure  1  1/531 (0.19%)  1 0/453 (0.00%) 
Skin and subcutaneous tissue disorders     
Hyperhidrosis  1  0/531 (0.00%)  1/453 (0.22%)  1
Vascular disorders     
Hypertension  1  0/531 (0.00%)  1/453 (0.22%)  1
Hypotension  1  1/531 (0.19%)  1 0/453 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Losartan-Based Regimen Alone (L Group) Diet Management and Losartan-Based Regimen (DML Group)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   55/531 (10.36%)      46/453 (10.15%)    
Blood and lymphatic system disorders     
Lymphadenopathy  1  0/531 (0.00%)  1/453 (0.22%)  1
Cardiac disorders     
Arrhythmia  1  0/531 (0.00%)  1/453 (0.22%)  1
Palpitations  1  1/531 (0.19%)  1 0/453 (0.00%) 
Eye disorders     
Eye irritation  1  1/531 (0.19%)  1 0/453 (0.00%) 
Vision blurred  1  1/531 (0.19%)  1 0/453 (0.00%) 
Gastrointestinal disorders     
Abdominal distension  1  1/531 (0.19%)  1 0/453 (0.00%) 
Abdominal mass  1  1/531 (0.19%)  1 0/453 (0.00%) 
Abdominal pain  1  2/531 (0.38%)  3 0/453 (0.00%) 
Abdominal pain upper  1  1/531 (0.19%)  1 0/453 (0.00%) 
Anal fissure  1  0/531 (0.00%)  1/453 (0.22%)  1
Diarrhoea  1  3/531 (0.56%)  5 2/453 (0.44%)  2
Dry mouth  1  0/531 (0.00%)  1/453 (0.22%)  1
Gastrooesophageal reflux disease  1  0/531 (0.00%)  1/453 (0.22%)  1
Nausea  1  2/531 (0.38%)  3 3/453 (0.66%)  3
Toothache  1  0/531 (0.00%)  1/453 (0.22%)  1
Vomiting  1  0/531 (0.00%)  1/453 (0.22%)  1
General disorders     
Asthenia  1  1/531 (0.19%)  1 1/453 (0.22%)  1
Chest discomfort  1  1/531 (0.19%)  1 0/453 (0.00%) 
Chest pain  1  2/531 (0.38%)  2 1/453 (0.22%)  1
Discomfort  1  1/531 (0.19%)  1 0/453 (0.00%) 
Drug ineffective  1  2/531 (0.38%)  2 0/453 (0.00%) 
Fatigue  1  4/531 (0.75%)  4 2/453 (0.44%)  2
Malaise  1  1/531 (0.19%)  1 0/453 (0.00%) 
Oedema  1  1/531 (0.19%)  2 0/453 (0.00%) 
Oedema peripheral  1  2/531 (0.38%)  2 1/453 (0.22%)  1
Immune system disorders     
Drug hypersensitivity  1  3/531 (0.56%)  3 0/453 (0.00%) 
Infections and infestations     
Anal abscess  1  0/531 (0.00%)  1/453 (0.22%)  1
Bronchitis  1  0/531 (0.00%)  1/453 (0.22%)  1
Gastroenteritis  1  0/531 (0.00%)  1/453 (0.22%)  1
Helicobacter gastritis  1  1/531 (0.19%)  1 0/453 (0.00%) 
Influenza  1  1/531 (0.19%)  1 0/453 (0.00%) 
Lower respiratory tract infection  1  0/531 (0.00%)  1/453 (0.22%)  1
Nail infection  1  0/531 (0.00%)  1/453 (0.22%)  1
Nasopharyngitis  1  0/531 (0.00%)  1/453 (0.22%)  1
Sinusitis  1  1/531 (0.19%)  1 2/453 (0.44%)  2
Upper respiratory tract infection  1  0/531 (0.00%)  3/453 (0.66%)  3
Injury, poisoning and procedural complications     
Drug exposure during pregnancy  1  1/531 (0.19%)  1 0/453 (0.00%) 
Fall  1  0/531 (0.00%)  1/453 (0.22%)  1
Incorrect dose administered  1  1/531 (0.19%)  1 0/453 (0.00%) 
Wrong technique in drug usage process  1  0/531 (0.00%)  1/453 (0.22%)  1
Investigations     
Blood pressure decreased  1  1/531 (0.19%)  1 2/453 (0.44%)  2
Blood pressure increased  1  1/531 (0.19%)  1 1/453 (0.22%)  1
C-reactive protein abnormal  1  1/531 (0.19%)  1 0/453 (0.00%) 
Creatinine urine increased  1  0/531 (0.00%)  1/453 (0.22%)  1
Heart rate increased  1  1/531 (0.19%)  1 0/453 (0.00%) 
Urea urine increased  1  0/531 (0.00%)  1/453 (0.22%)  1
Urine output decreased  1  0/531 (0.00%)  1/453 (0.22%)  1
Urine sodium increased  1  0/531 (0.00%)  1/453 (0.22%)  1
Weight increased  1  0/531 (0.00%)  1/453 (0.22%)  1
White blood cell count abnormal  1  0/531 (0.00%)  1/453 (0.22%)  1
Metabolism and nutrition disorders     
Decreased appetite  1  1/531 (0.19%)  1 0/453 (0.00%) 
Diabetes mellitus  1  0/531 (0.00%)  1/453 (0.22%)  1
Dyslipidaemia  1  1/531 (0.19%)  1 0/453 (0.00%) 
Fluid retention  1  0/531 (0.00%)  1/453 (0.22%)  1
Impaired fasting glucose  1  0/531 (0.00%)  1/453 (0.22%)  1
Type 2 diabetes mellitus  1  1/531 (0.19%)  1 0/453 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  0/531 (0.00%)  1/453 (0.22%)  1
Back pain  1  2/531 (0.38%)  2 0/453 (0.00%) 
Joint swelling  1  0/531 (0.00%)  1/453 (0.22%)  1
Muscle spasms  1  2/531 (0.38%)  2 2/453 (0.44%)  2
Musculoskeletal pain  1  0/531 (0.00%)  2/453 (0.44%)  2
Myalgia  1  3/531 (0.56%)  4 2/453 (0.44%)  2
Pain in extremity  1  1/531 (0.19%)  1 1/453 (0.22%)  1
Nervous system disorders     
Dizziness  1  11/531 (2.07%)  11 6/453 (1.32%)  6
Dizziness postural  1  0/531 (0.00%)  1/453 (0.22%)  1
Headache  1  7/531 (1.32%)  8 6/453 (1.32%)  6
Hypoaesthesia  1  1/531 (0.19%)  2 0/453 (0.00%) 
Somnolence  1  1/531 (0.19%)  1 0/453 (0.00%) 
Syncope  1  0/531 (0.00%)  1/453 (0.22%)  1
Psychiatric disorders     
Adjustment disorder  1  0/531 (0.00%)  1/453 (0.22%)  1
Anxiety  1  1/531 (0.19%)  1 2/453 (0.44%)  2
Depression  1  1/531 (0.19%)  1 1/453 (0.22%)  1
Insomnia  1  1/531 (0.19%)  1 0/453 (0.00%) 
Personality disorder  1  0/531 (0.00%)  1/453 (0.22%)  1
Stress  1  1/531 (0.19%)  1 1/453 (0.22%)  1
Renal and urinary disorders     
Microalbuminuria  1  0/531 (0.00%)  1/453 (0.22%)  1
Renal cyst  1  1/531 (0.19%)  1 0/453 (0.00%) 
Erectile dysfunction  1  0/531 (0.00%)  1/453 (0.22%)  1
Respiratory, thoracic and mediastinal disorders     
Cough  1  1/531 (0.19%)  1 3/453 (0.66%)  3
Rhinitis allergic  1  0/531 (0.00%)  1/453 (0.22%)  1
Skin and subcutaneous tissue disorders     
Rash  1  2/531 (0.38%)  2 1/453 (0.22%)  1
Rash maculo-papular  1  0/531 (0.00%)  1/453 (0.22%)  1
Surgical and medical procedures     
Endometrial ablation  1  0/531 (0.00%)  1/453 (0.22%)  1
Vascular disorders     
Hypertension  1  1/531 (0.19%)  1 1/453 (0.22%)  1
Hypotension  1  6/531 (1.13%)  6 2/453 (0.44%)  2
Labile blood pressure  1  0/531 (0.00%)  1/453 (0.22%)  1
Orthostatic hypotension  1  2/531 (0.38%)  2 1/453 (0.22%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.0)
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.
Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp
Phone: 1-800-672-6372
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00739674     History of Changes
Other Study ID Numbers: 0954A-335
2008_022
MK0954A-335
First Submitted: August 20, 2008
First Posted: August 22, 2008
Results First Submitted: July 14, 2010
Results First Posted: August 11, 2010
Last Update Posted: May 5, 2017