Sponsor study identifier
Secondary identifiers
interventional
261
0 countries
N/A
Study Start
February 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2007
Actual (reported)Study Completion
March 2007
Actual (reported)This is a 16-week study to evaluate high systolic and diastolic blood pressure following treatment in obese, hypertensive, adult patients.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2007
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2006
Date type not reportedThis date has not been verified as actual or estimated.
February 8, 2006
Actual (reported)February 10, 2006
Actual (reported)February 2007
Actual (reported)March 2007
Actual (reported)May 27, 2010
Actual (reported)Mean Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 8
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.
At baseline and at 8 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM)
Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 8
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.
At baseline and at 8 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM)
Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12
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.
At baseline and at 12 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM)
Mean Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 12
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.
At baseline and at 12 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM)
Mean Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 16
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.
At baseline and at 16 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM)
Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 16
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.
At baseline and at 16 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM)
Losartan
Placebo
Placebo to losartan once daily for 4 weeks in run-in period. Then, losartan 50 mg for 4 weeks, then titrate to losartan 100 mg at Week 4, then titrate to losartan 100 mg + hydrochlorothiazide (HCTZ) 12.5 mg at Week 8, and finally titrate to losartan 100 mg + HCTZ 25 mg at Week 12. Duration of treatment is approximately 16 weeks.
Placebo to losartan once daily for 4 weeks in run-in period. Then, placebo to losartan or losartan/HCTZ once daily for approximately 16 weeks.
Oparil S, Abate N, Chen E, Creager MA, Galet V, Jia G, Julius S, Lerman A, Lyle PA, Pool J, Tershakovec AM. A double-blind, randomized study evaluating losartan potassium monotherapy or in combination with hydrochlorothiazide versus placebo in obese patients with hypertension. Curr Med Res Opin. 2008 Apr;24(4):1101-14. doi: 10.1185/030079908x280716. Epub 2008 Mar 6.
Medical Monitor
Merck Sharp & Dohme LLC
261 participants (actual enrollment reported by the registry).
First Submitted
February 8, 2006
First Posted
February 10, 2006
Study Start
February 2006
Date type not reportedThis date has not been verified as actual or estimated.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
February 2007
Actual (reported)Study Completion
March 2007
Actual (reported)Last Updated
February 9, 2022
Results First Posted
May 27, 2010
Record last verified: 2022-02
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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