Phase 3
N=428
MK0954 Versus Placebo for Treatment of Mild to Moderate Hypertension
Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT00888355 ↗Enrolled (actual)
428
Serious AEs
—
Results posted
Jun 2009
Primary outcome: Primary: Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12 — -2.0; -5.8; -6.3; -8.0 mm Hg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- losartan potassium (Drug); Comparator: placebo (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Jan 1993
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12 |
-2.0; -5.8; -6.3; -8.0 | — |
| SECONDARY Mean Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) as Week 12 |
-0.2; -7.2; -7.6; -8.8 | — |
| SECONDARY Mean Change From Baseline in Peak Sitting Diastolic Blood Pressure (SiDBP) at Week 12 |
-3.0; -7.7; -8.7; -9.9 | — |
| SECONDARY Categories of Antihypertensive Response in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12 |
12; 23; 26; 33; 10; 14 | — |
Summary
The study had a 4 week single blind placebo period followed by 12 weeks of double blind treatment. Patients were randomized to one of four treatment arms to evaluate the antihypertensive efficacy of Losartan.
Eligibility Criteria
Inclusion Criteria
- Patient has been diagnosed with mild to moderate hypertension
- Patient has no treatment or active medical problem, other than hypertension that might affect the patients blood pressure
Exclusion Criteria
- Pregnant of lactating female patients
- Secondary hypertension or history of malignant hypertension
- Sitting systolic blood pressure > 210 mmHg
- History of stroke
- History of myocardial infarction with in the past year
- Current of prior history of heart failure
- Known hypersensitivity to losartan
- Obesity
- Patients known to be HIV positive or known to be positive for Hepatitis B
- Absence of one kidney
- Patient is abusing or previously abused alcohol or drugs with in past two years
Data sourced from ClinicalTrials.gov (NCT00888355). 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.