Phase 3
Completed N=122
A Study to Investigate the Magnitude and Duration of Response of MK0954 Compared to Placebo in Patients With Hypertension (0954-021)(COMPLETED)
Source: ClinicalTrials.gov NCT00886600 ↗Enrolled (actual)
122
Serious AEs
—
Results posted
Jul 2009
Primary outcomePrimary: Mean Change From Baseline in 24-hour Diastolic Ambulatory Blood Pressure Monitoring (ABPM) at Week 4 — -0.2; -5.2; -6.4; -8.5 mm Hg
Summary
The purpose of this study was to evaluate the magnitude and durations of the antihypertensive effects of losartan using ambulatory blood pressure monitoring (ABPM), and to evaluate the safety of losartan 50 and 100 mg doses compared to placebo.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in 24-hour Diastolic Ambulatory Blood Pressure Monitoring (ABPM) at Week 4 |
-0.2; -5.2; -6.4; -8.5 | — |
| PRIMARY Mean Change From Baseline in 24-hour Systolic Ambulatory Blood Pressure Monitoring (ABPM) at Week 4 |
0; -9.2; -9.9; -13.2 | — |
| SECONDARY Mean Change From Baseline in Sitting Diastolic Blood Pressure (siDBP) 24 Hours After Morning Dose at Week 4 |
-2.1; -6.7; -9.6; -8.8 | — |
| SECONDARY Mean Change From Baseline in Sitting Diastolic Blood Pressure (siDBP) After Adding HCTZ 24 Hours After Morning Dose at Week 6 |
-4.6; -9.9; -10.7; -10.1 | — |
| SECONDARY Mean Change From Week 4 in Sitting Diastolic Blood Pressure (siDBP) Adding HCTZ 24 Hours After Morning Dose at Week 6 |
-4.0; -5.1; -4.0; -4.0 | — |
Eligibility Criteria
Inclusion Criteria
- Non-black men and women with mild to moderate hypertension and within 30% of their ideal body weight
- Patient is in good general health
- Blood pressure at time of randomization is 95-115 mm Hg
Exclusion Criteria
- Secondary Hypertension or history of malignant hypertension
- History of stroke
- History of myocardial infarction
- Atrial flutter or atrial fibrillation
- History of congestive Heart failure
- Patient taking major psychotropic agent or anti-depressant
- Patient regularly uses NSAIDS or high dose aspirin
- Known positive test for HIV/AIDS or Hepatitis B
- Patient is being treated for acute ulcer disease
- Prior exposure to losartan
- Actively treated diabetes mellitus
- History of chronic liver disease
- Actively treated diabetes mellitus
- Any known bleeding or platelet disorder
- Absence of one kidney
- Women of childbearing potential
- Alcoholism or drug addiction
Data sourced from ClinicalTrials.gov (NCT00886600). 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.