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Trial record 26 of 65 for:    HYDROCHLOROTHIAZIDE AND VALSARTAN

BP-EASE -Effectiveness of Losartan 50 mg/Hydrochlorothiazide (HCTZ) 12.5 mg Versus Valsartan 80 mg/HCTZ 12.5 mg Titrated as Needed in Patients With Essential Hypertension Not Controlled on Monotherapy (0954A-333) (EASE)

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ClinicalTrials.gov Identifier: NCT00546754
Recruitment Status : Completed
First Posted : October 19, 2007
Results First Posted : April 13, 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
Drug: Comparator: Valsartan (+) Hydrochlorothiazide
Enrollment 808
Recruitment Details

First patient in: MAY-04-2007

Last patient out: APRIL-16-2009

Total number of sites: 163 sites in Canada

Pre-assignment Details  
Arm/Group Title Losartan 50 mg/HCTZ 12.5 mg Valsartan 80 mg/HCTZ 12.5 mg
Hide Arm/Group Description Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure. Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
Period Title: Overall Study
Started 425 [1] 383 [1]
Treated 416 [2] 373 [2]
Week 6 396 347
Week 12 375 334
Completed 375 334
Not Completed 50 49
Reason Not Completed
Serious Adverse Event             1             1
Adverse Event             11             16
Lack of Efficacy             1             1
Lost to Follow-up             9             15
Protocol Violation             3             0
Withdrawal by Subject             6             7
Dyspnea             1             0
Per Data Query, Less Than 4 Wks Coversyl             1             0
Hip Replacement             1             0
Suicide             1             0
Missing Cooperation             1             0
Elevated Creatinine and Potassium levels             0             1
Patient's Decision             0             1
Missing             14             7
[1]
Number of patients enrolled and randomized
[2]
Patients that received at least one dose of study medication and had 1 follow-up visit
Arm/Group Title Losartan 50 mg/HCTZ 12.5 mg Valsartan 80 mg/HCTZ 12.5 mg Total
Hide Arm/Group Description

Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.

416 number of patients that received at least one dose of study medication and had 1 follow-up visit (intent-to-treat population [ITT])

Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.

373 – number of patients that received at least one dose of study medication and had 1 follow-up visit (intent-to-treat population [ITT])

Total of all reporting groups
Overall Number of Baseline Participants 416 373 789
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 416 participants 373 participants 789 participants
58.7  (11.11) 58.3  (10.26) 58.5  (10.71)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 416 participants 373 participants 789 participants
Female
197
  47.4%
180
  48.3%
377
  47.8%
Male
219
  52.6%
193
  51.7%
412
  52.2%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 416 participants 373 participants 789 participants
Caucasian 364 326 690
Black 8 13 21
Hispanic 2 0 2
Asian 34 29 63
Native 4 4 8
East Indian 1 0 1
From Middle East 1 0 1
Unknown 2 1 3
1.Primary Outcome
Title Change in Systolic Blood Pressure From Baseline to Week 12
Hide Description [Not Specified]
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
416 and 373 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 371 and 331 patients at week 12 for Losartan 50/HCTZ 12.5mg and Valsartan 80/HCTZ 12.5mg respectively
Arm/Group Title Losartan 50 mg/HCTZ 12.5 mg Valsartan 80 mg/HCTZ 12.5 mg
Hide Arm/Group Description:
Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
Overall Number of Participants Analyzed 371 331
Mean (Standard Deviation)
Unit of Measure: mm Hg
-19.9  (13.79) -20.8  (13.61)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Losartan 50 mg/HCTZ 12.5 mg, Valsartan 80 mg/HCTZ 12.5 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.395
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
2.Primary Outcome
Title Change in Diastolic Blood Pressure From Baseline to Week 12
Hide Description [Not Specified]
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
416 and 373 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 371 and 331 patients at week 12 for Losartan 50/HCTZ 12.5mg and Valsartan 80/HCTZ 12.5mg respectively
Arm/Group Title Losartan 50 mg/HCTZ 12.5 mg Valsartan 80 mg/HCTZ 12.5 mg
Hide Arm/Group Description:
Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
Overall Number of Participants Analyzed 371 331
Mean (Standard Deviation)
Unit of Measure: mm Hg
-10.6  (9.28) -10.5  (9.58)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Losartan 50 mg/HCTZ 12.5 mg, Valsartan 80 mg/HCTZ 12.5 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.935
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
3.Secondary Outcome
Title Change in Systolic Blood Pressure From Baseline to Week 6
Hide Description [Not Specified]
Time Frame Baseline and Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
416 and 373 – 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 344 patients at week 6 for Losartan 50/HCTZ 12.5mg and Valsartan 80/HCTZ 12.5mg respectively
Arm/Group Title Losartan 50 mg/HCTZ 12.5 mg Valsartan 80 mg/HCTZ 12.5 mg
Hide Arm/Group Description:
Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
Overall Number of Participants Analyzed 392 344
Mean (Standard Deviation)
Unit of Measure: mm Hg
-16.7  (14.70) -18.2  (13.84)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Losartan 50 mg/HCTZ 12.5 mg, Valsartan 80 mg/HCTZ 12.5 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.153
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
4.Secondary Outcome
Title Change in Diastolic Blood Pressure From Baseline to Week 6
Hide Description [Not Specified]
Time Frame Baseline and Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
416 and 373 – 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 344 patients at week 6 for Losartan 50/HCTZ 12.5mg and Valsartan 80/HCTZ 12.5mg respectively
Arm/Group Title Losartan 50 mg/HCTZ 12.5 mg Valsartan 80 mg/HCTZ 12.5 mg
Hide Arm/Group Description:
Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
Overall Number of Participants Analyzed 392 344
Mean (Standard Deviation)
Unit of Measure: mm Hg
-8.4  (9.35) -9.1  (9.16)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Losartan 50 mg/HCTZ 12.5 mg, Valsartan 80 mg/HCTZ 12.5 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.343
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
5.Secondary Outcome
Title Number of Patients Achieving Target Blood Pressure at Week 6
Hide Description Number of Patients Achieving Target Blood Pressure (<140/90 mm Hg and <130/80 mm Hg for diabetics) at week 6
Time Frame Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
416 and 373 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 393 and 345 patients at week 6 for Losartan 50/HCTZ 12.5mg and Valsartan 80/HCTZ 12.5mg respectively
Arm/Group Title Losartan 50 mg/HCTZ 12.5 mg Valsartan 80 mg/HCTZ 12.5 mg
Hide Arm/Group Description:
Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
Overall Number of Participants Analyzed 393 345
Measure Type: Number
Unit of Measure: Patients
Achieved Target Blood Pressure 253 241
Did Not Achieve Target Blood Pressure 140 104
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Losartan 50 mg/HCTZ 12.5 mg, Valsartan 80 mg/HCTZ 12.5 mg
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]
6.Secondary Outcome
Title Number of Patients Achieving Target Blood Pressure at Week 12
Hide Description Number of Patients Achieving Target Blood Pressure (<140/90 mm Hg and <130/80 mm Hg for diabetics) at week 12
Time Frame 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
416 and 373 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 372 and 332 patients at week 12 for Losartan 50/HCTZ 12.5mg and Valsartan 80/HCTZ 12.5mg respectively
Arm/Group Title Losartan 50 mg/HCTZ 12.5 mg Valsartan 80 mg/HCTZ 12.5 mg
Hide Arm/Group Description:
Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
Overall Number of Participants Analyzed 372 332
Measure Type: Number
Unit of Measure: Patients
Achieved Target Blood Pressure 278 253
Did Not Achieve Target Blood Pressure 94 79
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Losartan 50 mg/HCTZ 12.5 mg, Valsartan 80 mg/HCTZ 12.5 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.662
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
7.Secondary Outcome
Title Time to Achieve Target Blood Pressure
Hide Description Time to achieve the target blood pressure (<140/90 mmHg and <130/80 mmHg for diabetics)
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
416 and 373 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 406 and 360 patients for Losartan 50/HCTZ 12.5mg and Valsartan 80/HCTZ 12.5mg respectively
Arm/Group Title Losartan 50 mg/HCTZ 12.5 mg Valsartan 80 mg/HCTZ 12.5 mg
Hide Arm/Group Description:
Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
Overall Number of Participants Analyzed 406 360
Mean (Standard Deviation)
Unit of Measure: Days
62.3  (1.44) 57.3  (1.24)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Losartan 50 mg/HCTZ 12.5 mg, Valsartan 80 mg/HCTZ 12.5 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.020
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
8.Secondary Outcome
Title Change in Uric Acid From Baseline to Week 6
Hide Description [Not Specified]
Time Frame Baseline and Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
416 and 373 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 298 and 269 patients at week 6 for Losartan 50/HCTZ 12.5mg and Valsartan 80/HCTZ 12.5mg respectively
Arm/Group Title Losartan 50 mg/HCTZ 12.5 mg Valsartan 80 mg/HCTZ 12.5 mg
Hide Arm/Group Description:
Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
Overall Number of Participants Analyzed 298 269
Mean (Standard Deviation)
Unit of Measure: umol/L
0.3  (53.12) 21.7  (55.09)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Losartan 50 mg/HCTZ 12.5 mg, Valsartan 80 mg/HCTZ 12.5 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
9.Secondary Outcome
Title Change in Uric Acid From Baseline to Week 12
Hide Description [Not Specified]
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
416 and 373 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 286 and 253 patients at week 12 for Losartan 50/HCTZ 12.5mg and Valsartan 80/HCTZ 12.5mg respectively
Arm/Group Title Losartan 50 mg/HCTZ 12.5 mg Valsartan 80 mg/HCTZ 12.5 mg
Hide Arm/Group Description:
Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
Overall Number of Participants Analyzed 286 253
Mean (Standard Deviation)
Unit of Measure: umol/L
-0.4  (57.02) 29.9  (64.79)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Losartan 50 mg/HCTZ 12.5 mg, Valsartan 80 mg/HCTZ 12.5 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
10.Secondary Outcome
Title Change in Serum Highly Sensitive C-reactive Protein From Baseline to Week 6
Hide Description [Not Specified]
Time Frame Baseline and Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
416 and 373 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 304 and 272 patients at week 6 for Losartan 50/HCTZ 12.5mg and Valsartan 80/HCTZ 12.5mg respectively
Arm/Group Title Losartan 50 mg/HCTZ 12.5 mg Valsartan 80 mg/HCTZ 12.5 mg
Hide Arm/Group Description:
Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
Overall Number of Participants Analyzed 304 272
Mean (Standard Deviation)
Unit of Measure: mg/L
0.8  (26.21) 0.6  (6.60)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Losartan 50 mg/HCTZ 12.5 mg, Valsartan 80 mg/HCTZ 12.5 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.899
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
11.Secondary Outcome
Title Change in Serum Highly Sensitive C-reactive Protein From Baseline to Week 12
Hide Description [Not Specified]
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
416 and 373 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 279 and 255 patients at week 12 for Losartan 50/HCTZ 12.5mg and Valsartan 80/HCTZ 12.5mg respectively
Arm/Group Title Losartan 50 mg/HCTZ 12.5 mg Valsartan 80 mg/HCTZ 12.5 mg
Hide Arm/Group Description:
Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
Overall Number of Participants Analyzed 279 255
Mean (Standard Deviation)
Unit of Measure: umol/L
-0.3  (8.05) 0.5  (7.20)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Losartan 50 mg/HCTZ 12.5 mg, Valsartan 80 mg/HCTZ 12.5 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.218
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
12.Secondary Outcome
Title Change in Gamma-Glutamyl Transpeptidase (Gamma-GT) From Baseline to Week 6
Hide Description [Not Specified]
Time Frame Baseline and Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
416 and 373 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 300 and 273 patients at week 6 for Losartan 50/HCTZ 12.5mg and Valsartan 80/HCTZ 12.5mg respectively
Arm/Group Title Losartan 50 mg/HCTZ 12.5 mg Valsartan 80 mg/HCTZ 12.5 mg
Hide Arm/Group Description:
Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
Overall Number of Participants Analyzed 300 273
Mean (Standard Deviation)
Unit of Measure: IU/L
-1.8  (21.20) -0.1  (24.71)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Losartan 50 mg/HCTZ 12.5 mg, Valsartan 80 mg/HCTZ 12.5 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.386
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
13.Secondary Outcome
Title Change in Gamma-Glutamyl Transpeptidase (Gamma–GT) From Baseline to Week 12
Hide Description [Not Specified]
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
416 and 373 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 279 and 254 patients at week 12 for Losartan 50/HCTZ 12.5mg and Valsartan 80/HCTZ 12.5mg respectively
Arm/Group Title Losartan 50 mg/HCTZ 12.5 mg Valsartan 80 mg/HCTZ 12.5 mg
Hide Arm/Group Description:
Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
Overall Number of Participants Analyzed 279 254
Mean (Standard Deviation)
Unit of Measure: IU/L
-0.7  (21.44) -0.0  (24.45)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Losartan 50 mg/HCTZ 12.5 mg, Valsartan 80 mg/HCTZ 12.5 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.725
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Losartan 50 mg/HCTZ 12.5 mg Valsartan 80 mg/HCTZ 12.5 mg
Hide Arm/Group Description Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure. Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
All-Cause Mortality
Losartan 50 mg/HCTZ 12.5 mg Valsartan 80 mg/HCTZ 12.5 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Losartan 50 mg/HCTZ 12.5 mg Valsartan 80 mg/HCTZ 12.5 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/425 (2.59%)      5/383 (1.31%)    
Cardiac disorders     
Acute myocardial infarction  1  1/425 (0.24%)  1 0/383 (0.00%)  0
Gastrointestinal disorders     
Barrett’s oesophagus  1  1/425 (0.24%)  1 0/383 (0.00%)  0
Gastrointestinal haemorrhage  1  1/425 (0.24%)  1 0/383 (0.00%)  0
General disorders     
Chest pain  1  0/425 (0.00%)  0 1/383 (0.26%)  1
Hepatobiliary disorders     
Cholecystitis acute  1  0/425 (0.00%)  0 1/383 (0.26%)  1
Infections and infestations     
Pneumonia klebsiella  1  1/425 (0.24%)  1 0/383 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Lung neoplasm  1  1/425 (0.24%)  1 0/383 (0.00%)  0
Multiple myeloma  1  1/425 (0.24%)  1 0/383 (0.00%)  0
Nervous system disorders     
Cerebrovascular accident  1  1/425 (0.24%)  1 0/383 (0.00%)  0
Critical illness polyneuropathy  1  1/425 (0.24%)  1 0/383 (0.00%)  0
Syncope  1  1/425 (0.24%)  1 2/383 (0.52%)  2
Psychiatric disorders     
Completed suicide  1  1/425 (0.24%)  1 0/383 (0.00%)  0
Renal and urinary disorders     
Renal failure  1  0/425 (0.00%)  0 1/383 (0.26%)  1
Renal failure acute  1  1/425 (0.24%)  1 0/383 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Pulmonary oedema  1  0/425 (0.00%)  0 1/383 (0.26%)  1
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 50 mg/HCTZ 12.5 mg Valsartan 80 mg/HCTZ 12.5 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   56/425 (13.18%)      57/383 (14.88%)    
Ear and labyrinth disorders     
Vertigo * 1  0/425 (0.00%)  0 1/383 (0.26%)  1
Eye disorders     
Visual disturbance * 1  1/425 (0.24%)  1 0/383 (0.00%)  0
Gastrointestinal disorders     
Abdominal discomfort * 1  0/425 (0.00%)  0 1/383 (0.26%)  1
Abdominal pain upper * 1  3/425 (0.71%)  3 1/383 (0.26%)  1
Diarrhoea * 1  3/425 (0.71%)  3 0/383 (0.00%)  0
Gastritis * 1  1/425 (0.24%)  1 0/383 (0.00%)  0
Gastrointestinal disorder * 1  1/425 (0.24%)  1 0/383 (0.00%)  0
Nausea * 1  0/425 (0.00%)  0 1/383 (0.26%)  1
Stomach discomfort * 1  2/425 (0.47%)  2 0/383 (0.00%)  0
Swollen tongue * 1  0/425 (0.00%)  0 1/383 (0.26%)  1
Vomiting * 1  0/425 (0.00%)  0 2/383 (0.52%)  2
General disorders     
Dyspepsia * 1  0/425 (0.00%)  0 1/383 (0.26%)  1
Asthenia * 1  1/425 (0.24%)  1 1/383 (0.26%)  1
Chest discomfort * 1  1/425 (0.24%)  1 0/383 (0.00%)  0
Chest pain * 1  1/425 (0.24%)  1 0/383 (0.00%)  0
Fatigue * 1  1/425 (0.24%)  1 0/383 (0.00%)  0
Feeling abnormal * 1  1/425 (0.24%)  1 0/383 (0.00%)  0
Inflammation * 1  0/425 (0.00%)  0 1/383 (0.26%)  1
Malaise * 1  0/425 (0.00%)  0 1/383 (0.26%)  1
Pain * 1  1/425 (0.24%)  1 0/383 (0.00%)  0
Slugishness * 1  1/425 (0.24%)  1 0/383 (0.00%)  0
Immune system disorders     
Hypersensitivity * 1  0/425 (0.00%)  0 2/383 (0.52%)  2
Infections and infestations     
Bronchitis * 1  1/425 (0.24%)  1 1/383 (0.26%)  1
Gastroenteritis * 1  0/425 (0.00%)  0 1/383 (0.26%)  1
Helicobacter infection * 1  0/425 (0.00%)  0 1/383 (0.26%)  1
Influenza * 1  1/425 (0.24%)  1 0/383 (0.00%)  0
Mastitis * 1  0/425 (0.00%)  0 1/383 (0.26%)  1
Rhinitis * 1  1/425 (0.24%)  1 0/383 (0.00%)  0
Sinusitis * 1  1/425 (0.24%)  1 0/383 (0.00%)  0
Upper respiratory tract infection * 1  0/425 (0.00%)  0 1/383 (0.26%)  1
Injury, poisoning and procedural complications     
Back injury * 1  1/425 (0.24%)  1 1/383 (0.26%)  1
Back sprain * 1  1/425 (0.24%)  1 0/383 (0.00%)  0
Incorrect does administered * 1  0/425 (0.00%)  0 1/383 (0.26%)  1
Neck injury * 1  0/425 (0.00%)  0 1/383 (0.26%)  1
Wrong technique in drug usage process * 1  0/425 (0.00%)  0 2/383 (0.52%)  2
Investigations     
Blood creatinine increased * 1  2/425 (0.47%)  2 0/383 (0.00%)  0
Blood glucose increased * 1  0/425 (0.00%)  0 1/383 (0.26%)  1
Blood potassium abnormal * 1  0/425 (0.00%)  0 1/383 (0.26%)  1
Blood potassium increased * 1  3/425 (0.71%)  3 1/383 (0.26%)  1
Blood pressure decreased * 1  0/425 (0.00%)  0 1/383 (0.26%)  1
C-Reactive protein increased * 1  7/425 (1.65%)  7 3/383 (0.78%)  3
Cardiac murmur * 1  1/425 (0.24%)  1 0/383 (0.00%)  0
Gamma-glutamyltransferase increased * 1  0/425 (0.00%)  0 1/383 (0.26%)  1
Heart rate increased * 1  1/425 (0.24%)  1 0/383 (0.00%)  0
Metabolism and nutrition disorders     
Dehydration * 1  0/425 (0.00%)  0 1/383 (0.26%)  1
Diabetes mellitus * 1  1/425 (0.24%)  1 1/383 (0.26%)  1
Hyperkalemia * 1  1/425 (0.24%)  1 0/383 (0.00%)  0
Hypokalemia * 1  0/425 (0.00%)  0 1/383 (0.26%)  1
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  2/425 (0.47%)  2 1/383 (0.26%)  1
Back pain * 1  0/425 (0.00%)  0 1/383 (0.26%)  1
Joint stiffness * 1  1/425 (0.24%)  1 0/383 (0.00%)  0
Myalgia * 1  0/425 (0.00%)  0 2/383 (0.52%)  2
Pain in extremity * 1  1/425 (0.24%)  1 0/383 (0.00%)  0
Nervous system disorders     
Dizziness  3/425 (0.71%)  3 4/383 (1.04%)  4
Headache * 1  4/425 (0.94%)  4 4/383 (1.04%)  4
Tremor * 1  0/425 (0.00%)  0 1/383 (0.26%)  1
Psychiatric disorders     
Anxiety * 1  1/425 (0.24%)  1 1/383 (0.26%)  1
Depression * 1  0/425 (0.00%)  0 1/383 (0.26%)  1
Mood swings * 1  0/425 (0.00%)  0 1/383 (0.26%)  1
Renal impairment * 1  0/425 (0.00%)  0 1/383 (0.26%)  1
Renal and urinary disorders     
Urinary retention * 1  0/425 (0.00%)  0 1/383 (0.26%)  1
Respiratory, thoracic and mediastinal disorders     
Cough * 1  2/425 (0.47%)  2 0/383 (0.00%)  0
Dyspnoea * 1  1/425 (0.24%)  1 0/383 (0.00%)  0
Productive cough * 1  1/425 (0.24%)  1 0/383 (0.00%)  0
Skin and subcutaneous tissue disorders     
Night sweats * 1  0/425 (0.00%)  0 1/383 (0.26%)  1
Swelling face  0/425 (0.00%)  0 1/383 (0.26%)  1
Surgical and medical procedures     
Inguinal hernia repair * 1  0/425 (0.00%)  0 1/383 (0.26%)  1
Vascular disorders     
Hot flush * 1  0/425 (0.00%)  0 1/383 (0.26%)  1
Hypotension * 1  0/425 (0.00%)  0 1/383 (0.26%)  1
*
Indicates events were collected by non-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: NCT00546754     History of Changes
Other Study ID Numbers: 0954A-333
MK0954A-333
2007_031
First Submitted: October 17, 2007
First Posted: October 19, 2007
Results First Submitted: March 26, 2010
Results First Posted: April 13, 2010
Last Update Posted: May 5, 2017