Phase 3
N=261
Obese Hypertension Study (0954-315)
Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT00289887 ↗Enrolled (actual)
261
Serious AEs
0.8%
Results posted
May 2010
Primary outcome: Primary: Mean Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 8 — -12.1; -6.8 mm Hg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Comparator: losartan +/- HCTZ (Drug); Comparator: Placebo (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Organon and Co
- Primary completion
- Feb 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 8 |
-12.1; -6.8 | — |
| PRIMARY Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 8 |
-9.7; -6.9 | — |
| PRIMARY Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12 |
-12.9; -7.1 | — |
| PRIMARY Mean Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 12 |
-16.7; -6.8 | — |
| PRIMARY Mean Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 16 |
-19.1; -6.4 | — |
| PRIMARY Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 16 |
-14.1; -6.0 | — |
Summary
This is a 16-week study to evaluate high systolic and diastolic blood pressure following treatment in obese, hypertensive, adult patients.
Eligibility Criteria
Inclusion Criteria
- Obese male and female patients, ages 21-75 years, with high blood pressure
Exclusion Criteria
- Patients cannot have any other severe cardiac conditions
Data sourced from ClinicalTrials.gov (NCT00289887). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.