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Obese Hypertension Study (0954-315)

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ClinicalTrials.gov Identifier: NCT00289887
Recruitment Status : Completed
First Posted : February 10, 2006
Results First Posted : May 27, 2010
Last Update Posted : July 28, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Hypertension
Interventions Drug: Comparator: losartan +/- HCTZ
Drug: Comparator: Placebo
Enrollment 261

Recruitment Details

Patients were recruited at 51 sites in the United States.

Prime Therapy Period: April 2006 to February 2007

Pre-assignment Details Prior antihypertensive medications were withdrawn/ tapered before patients entered the 4-week placebo run-in period.
Arm/Group Title Losartan Placebo
Hide Arm/Group Description Once-daily losartan 50 mg titrated at 4-week intervals to losartan 100 mg, losartan 100 mg/Hydrochlorothiazide (HCTZ) 12.5 mg, and losartan 100 mg/HCTZ 25 mg Once-daily matching placebo for losartan 50 mg titrated at 4-week intervals to matching placebo for losartan 100 mg, matching placebo for losartan 100 mg/HCTZ 12.5 mg, and matching placebo for losartan 100 mg/HCTZ 25 mg
Period Title: Overall Study
Started 127 134
Completed 105 105
Not Completed 22 29
Reason Not Completed
Adverse Event             3             3
Lack of Efficacy             3             11
Lost to Follow-up             3             3
Protocol Violation             3             1
Withdrawal by Subject             3             8
Other             7             3
Arm/Group Title Losartan Placebo Total
Hide Arm/Group Description Once-daily losartan 50 mg titrated at 4-week intervals to losartan 100 mg, losartan 100 mg/Hydrochlorothiazide (HCTZ) 12.5 mg, and losartan 100 mg/HCTZ 25 mg Once-daily matching placebo for losartan 50 mg titrated at 4-week intervals to matching placebo for losartan 100 mg, matching placebo for losartan 100 mg/HCTZ 12.5 mg, and matching placebo for losartan 100 mg/HCTZ 25 mg Total of all reporting groups
Overall Number of Baseline Participants 127 134 261
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 127 participants 134 participants 261 participants
50.1  (10.4) 51.4  (9.7) 50.8  (10.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 127 participants 134 participants 261 participants
Female
79
  62.2%
77
  57.5%
156
  59.8%
Male
48
  37.8%
57
  42.5%
105
  40.2%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 127 participants 134 participants 261 participants
Caucasian 84 87 171
Black 22 29 51
Hispanic American 20 16 36
Native American 0 1 1
Other 1 1 2
Sitting Diastolic Blood Pressure (SiDBP)  
Mean (Standard Deviation)
Unit of measure:  Mm Hg
Number Analyzed 127 participants 134 participants 261 participants
99.1  (4.2) 99.0  (4.0) 99.0  (4.1)
Sitting Systolic Blood Pressure (SiSBP)  
Mean (Standard Deviation)
Unit of measure:  Mm Hg
Number Analyzed 127 participants 134 participants 261 participants
151.6  (8.2) 152.4  (9.0) 152.0  (8.6)
1.Primary Outcome
Title Mean Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 8
Hide Description

Mean change from baseline in trough (6 hours after last morning dose) SiSBP at Week 8.

A mixed effects model (with repeated measurements including terms of treatment, investigators, week, baseline SiSBP(/SiDBP), plasma glucose stratum, treatment*week, and week*SiSBP(/SiDBP)) was used to compare the treatments on the change from baseline.

Time Frame At baseline and at 8 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
An "all patients treated" approach was employed, patients included had at least 1 dose post baseline and 1 measurement at baseline and during treatment.
Arm/Group Title Losartan Placebo
Hide Arm/Group Description:
Once-daily losartan 50 mg titrated at 4-week intervals to losartan 100 mg, losartan 100 mg/Hydrochlorothiazide (HCTZ) 12.5 mg, and losartan 100 mg/HCTZ 25 mg
Once-daily matching placebo for losartan 50 mg titrated at 4-week intervals to matching placebo for losartan 100 mg, matching placebo for losartan 100 mg/HCTZ 12.5 mg, and matching placebo for losartan 100 mg/HCTZ 25 mg
Overall Number of Participants Analyzed 119 117
Least Squares Mean (Standard Error)
Unit of Measure: mm Hg
-12.1  (1.2) -6.8  (1.2)
2.Primary Outcome
Title Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 8
Hide Description

Mean change from baseline in trough (6 hours after the last morning dose) SiDBP at Week 8.

A mixed effects model (with repeated measurements including terms of treatment, investigators, week, baseline SiSBP(/SiDBP), plasma glucose stratum, treatment*week, and week*SiSBP(/SiDBP)) was used to compare the treatments on the change from baseline.

Time Frame At baseline and at 8 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
An "all patients treated" approach was employed, patients included had at least 1 dose post baseline and 1 measurement at baseline and during treatment.
Arm/Group Title Losartan Placebo
Hide Arm/Group Description:
Once-daily losartan 50 mg titrated at 4-week intervals to losartan 100 mg, losartan 100 mg/Hydrochlorothiazide (HCTZ) 12.5 mg, and losartan 100 mg/HCTZ 25 mg
Once-daily matching placebo for losartan 50 mg titrated at 4-week intervals to matching placebo for losartan 100 mg, matching placebo for losartan 100 mg/HCTZ 12.5 mg, and matching placebo for losartan 100 mg/HCTZ 25 mg
Overall Number of Participants Analyzed 119 117
Least Squares Mean (Standard Error)
Unit of Measure: mm Hg
-9.7  (0.8) -6.9  (0.8)
3.Primary Outcome
Title Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12
Hide Description

Mean change from baseline in trough (6 hours after the last morning dose) SiDBP at Week 12.

A mixed effects model (with repeated measurements including terms of treatment, investigators, week, baseline SiSBP(/SiDBP), plasma glucose stratum, treatment*week, and week*SiSBP(/SiDBP)) was used to compare the treatments on the change from baseline.

Time Frame At baseline and at 12 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
An "all patients treated" approach was employed, patients included had at least 1 dose post baseline and 1 measurement at baseline and during treatment.
Arm/Group Title Losartan Placebo
Hide Arm/Group Description:
Once-daily losartan 50 mg titrated at 4-week intervals to losartan 100 mg, losartan 100 mg/Hydrochlorothiazide (HCTZ) 12.5 mg, and losartan 100 mg/HCTZ 25 mg
Once-daily matching placebo for losartan 50 mg titrated at 4-week intervals to matching placebo for losartan 100 mg, matching placebo for losartan 100 mg/HCTZ 12.5 mg, and matching placebo for losartan 100 mg/HCTZ 25 mg
Overall Number of Participants Analyzed 109 112
Least Squares Mean (Standard Error)
Unit of Measure: mm Hg
-12.9  (0.8) -7.1  (0.8)
4.Primary Outcome
Title Mean Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 12
Hide Description

Mean change from baseline in trough (6 hours after last morning dose) SiSBP at Week 12.

A mixed effects model (with repeated measurements including terms of treatment, investigators, week, baseline SiSBP(/SiDBP), plasma glucose stratum, treatment*week, and week*SiSBP(/SiDBP)) was used to compare the treatments on the change from baseline.

Time Frame At baseline and at 12 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
An "all patients treated" approach was employed, patients included had at least 1 dose post baseline and 1 measurement at baseline and during treatment.
Arm/Group Title Losartan Placebo
Hide Arm/Group Description:
Once-daily losartan 50 mg titrated at 4-week intervals to losartan 100 mg, losartan 100 mg/Hydrochlorothiazide (HCTZ) 12.5 mg, and losartan 100 mg/HCTZ 25 mg
Once-daily matching placebo for losartan 50 mg titrated at 4-week intervals to matching placebo for losartan 100 mg, matching placebo for losartan 100 mg/HCTZ 12.5 mg, and matching placebo for losartan 100 mg/HCTZ 25 mg
Overall Number of Participants Analyzed 109 112
Least Squares Mean (Standard Error)
Unit of Measure: mm Hg
-16.7  (1.3) -6.8  (1.3)
5.Primary Outcome
Title Mean Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 16
Hide Description

Mean change from baseline in trough (6 hours after last morning dose) SiSBP at Week 16.

A mixed effects model (with repeated measurements including terms of treatment, investigators, week, baseline SiSBP(/SiDBP), plasma glucose stratum, treatment*week, and week*SiSBP(/SiDBP)) was used to compare the treatments on the change from baseline.

Time Frame At baseline and at 16 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
An "all patients treated" approach was employed, patients included had at least 1 dose post baseline and 1 measurement at baseline and during treatment.
Arm/Group Title Losartan Placebo
Hide Arm/Group Description:
Once-daily losartan 50 mg titrated at 4-week intervals to losartan 100 mg, losartan 100 mg/Hydrochlorothiazide (HCTZ) 12.5 mg, and losartan 100 mg/HCTZ 25 mg
Once-daily matching placebo for losartan 50 mg titrated at 4-week intervals to matching placebo for losartan 100 mg, matching placebo for losartan 100 mg/HCTZ 12.5 mg, and matching placebo for losartan 100 mg/HCTZ 25 mg
Overall Number of Participants Analyzed 106 106
Least Squares Mean (Standard Error)
Unit of Measure: mm Hg
-19.1  (1.3) -6.4  (1.3)
6.Primary Outcome
Title Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 16
Hide Description

Mean change from baseline in trough (6 hours after the last morning dose) SiDBP at Week 16.

A mixed effects model (with repeated measurements including terms of treatment, investigators, week, baseline SiSBP(/SiDBP), plasma glucose stratum, treatment*week, and week*SiSBP(/SiDBP)) was used to compare the treatments on the change from baseline.

Time Frame At baseline and at 16 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
An "all patients treated" approach was employed, patients included had at least 1 dose post baseline and 1 measurement at baseline and during treatment.
Arm/Group Title Losartan Placebo
Hide Arm/Group Description:
Once-daily losartan 50 mg titrated at 4-week intervals to losartan 100 mg, losartan 100 mg/Hydrochlorothiazide (HCTZ) 12.5 mg, and losartan 100 mg/HCTZ 25 mg
Once-daily matching placebo for losartan 50 mg titrated at 4-week intervals to matching placebo for losartan 100 mg, matching placebo for losartan 100 mg/HCTZ 12.5 mg, and matching placebo for losartan 100 mg/HCTZ 25 mg
Overall Number of Participants Analyzed 106 106
Least Squares Mean (Standard Error)
Unit of Measure: mm Hg
-14.1  (0.9) -6.0  (0.9)
Time Frame Week 0 through Week 16.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Losartan Placebo
Hide Arm/Group Description Once-daily losartan 50 mg titrated at 4-week intervals to losartan 100 mg, losartan 100 mg/Hydrochlorothiazide (HCTZ) 12.5 mg, and losartan 100 mg/HCTZ 25 mg Once-daily matching placebo for losartan 50 mg titrated at 4-week intervals to matching placebo for losartan 100 mg, matching placebo for losartan 100 mg/HCTZ 12.5 mg, and matching placebo for losartan 100 mg/HCTZ 25 mg
All-Cause Mortality
Losartan Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Losartan Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   1/127 (0.79%)   1/134 (0.75%) 
Gastrointestinal disorders     
Pancreatitis acute * 1  1/127 (0.79%)  0/134 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Basal cell carcinoma * 1  0/127 (0.00%)  1/134 (0.75%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 9.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Losartan Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   4/127 (3.15%)   7/134 (5.22%) 
Nervous system disorders     
Headache * 1  4/127 (3.15%)  7/134 (5.22%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 9.1
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
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00289887     History of Changes
Other Study ID Numbers: 0954-315
MK0954-315
2006_002
First Submitted: February 8, 2006
First Posted: February 10, 2006
Results First Submitted: September 21, 2009
Results First Posted: May 27, 2010
Last Update Posted: July 28, 2015