Phase 4
N=15
A Study of Safety and Efficacy in MK-0954A Combination in Participants With Hypertension (MK-0954A-373 AM3)
Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT01431508 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Nov 2011
Primary outcome: Primary: Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12 — 99.2; -12.7 mm Hg — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Losartan 50 mg / HCTZ 12.5 mg (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Organon and Co
- Primary completion
- Jun 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12 |
99.2; -12.7 | <0.05 sig |
Summary
This study is being conducted to evaluate the safety and antihypertensive efficacy of MK-0954A (Losartan 50 mg / Hydrochlorothiazide (HCTZ) 12.5 mg) in participants with mild to moderate essential hypertension.
Eligibility Criteria
Inclusion criteria
- Participant will have reached the legal age by the time of entrance into the run-in period.
- Participant has no active medical problem, other than essential hypertension,
which might of itself or by this treatment significantly affect the Participant's blood pressure.
- Participants diagnosed with mild to moderate essential hypertension or
hypertension accompanying with established cardiovascular (CV) and renal diseases who are receiving antihypertensive regimen (exclude diuretic), yet not attaining to treatment goal*.
- Note: For essential hypertension, the goal is to reduce the blood pressure to less than 140/90. For hypertension with established CV and renal diseases, the BP goal is 210 mmHg at Visit 1 (Day 0).
- Participants with unresolved cerebrovascular accident or transient ischemic attack in the acute stage at visit 1.
- A clinically confirmed myocardial infarction within the recent 3 months.
- Angina pectoris.
- Clinically important cardiac arrhythmia.
- History of unexplained syncope within the prior 2 years, or a known syncopal
disorder.
- Presence of hemodynamically significant obstructive valvular disease of
cardiomyopathy.
- Percutaneous coronary angioplasty or coronary artery bypass surgery within the prior 3 months of visit 1.
- Participant with a single functioning kidney.
Data sourced from ClinicalTrials.gov (NCT01431508). 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.