Phase 2
Completed N=249
Safety and Efficacy of MK0736 & MK0916 in Patients With Hypertension (High Blood Pressure)(0736-003)(COMPLETED)
Source: ClinicalTrials.gov NCT00274716 ↗Enrolled (actual)
249
Serious AEs
3.6%
Results posted
Feb 2014
Primary outcomePrimary: Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12 in Participants With Higher Body Mass Indices (BMI) — -4.2; -2.4; -3.1; -0.2 mm Hg — p=0.157
Summary
The objective of this study is to evaluate the safety and efficacy of two investigational drugs (MK-0736 and MK-0916) in lowering blood pressure and body weight in patients with hypertension (high blood pressure).
This is an early phase trial and some specific protocol information is proprietary and not publicly available at this time. (Full information is available to trial participants).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12 in Participants With Higher Body Mass Indices (BMI) |
-4.2; -2.4; -3.1; -0.2 | 0.157 |
| PRIMARY Number of Participants Who Reported a Clinical Adverse Event |
44; 39; 38; 36; 16; 11 | — |
| PRIMARY Number of Participants Who Reported a Laboratory Adverse Event |
1; 2; 0; 2; 0; 0 | — |
| PRIMARY Number of Participants Who Were Discontinued From Study Due to Clinical Adverse Event |
2; 3; 6; 0; 2; 1 | — |
| PRIMARY Number of Participants Who Were Discontinued From Study Due to Laboratory Adverse Event |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 12 in Participants With Higher Body Mass Indices (BMI) |
-3.5; -4.2; -3.2; 0.7 | 0.046 sig |
| SECONDARY Change From Baseline in Body Weight (kg) at Week 12 in Participants With Higher BMI |
-0.6; -0.9; -1.2; 0.5 | <0.001 sig |
| SECONDARY Change From Baseline in Waist Circumference at Week 12 in Participants With Higher BMI |
-1.9; -0.9; -0.3; 1.2 | 0.059 |
| SECONDARY Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 in Participants With Higher Body Mass Indices (BMI) |
-1.0; -5.2; 4.5; 5.7 | 0.005 sig |
| SECONDARY Change From Baseline for High Density Lipoprotein Cholesterol (HDL-C) at Week 12 in Participants With Higher BMI |
-1.3; -1.8; 1.6; 1.5 | 0.015 sig |
| SECONDARY Percent Change From Baseline in Triglycerides (TG) at Week 12 in Participants With Higher Body Mass Indices (BMI) |
11.5; 20.1; 11.6; 11.1 | 0.587 |
Eligibility Criteria
Inclusion Criteria
- Hypertension systolic blood pressure (SBP) 40 kg/m2 (morbidly obese patients)
- History of Alcohol abuse (<3 Years)
- History of diabetes, chronic kidney disease, Active liver disease, recent heart attack or stroke
Data sourced from ClinicalTrials.gov (NCT00274716). 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. Informational only — not medical advice.