Clinical trial NCT00886600: A Study to Investigate the Magnitude and Duration of Response of MK0954 Compared to Placebo in Patients With Hypertension (0954-021)(COMPLETED)
Official title: A Double-blind, Randomized, Parallel-group, Placebo-controlled Pilot Study to Investigate the Magnitude and Duration of Response and the Safety of MK0954 (50 mg Given Once or Twice Daily, or 100 mg Given Once Daily) Compared to Placebo Using Ambulatory Blood Pressure Monitoring
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-04-23
Enrollment: 122
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


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

Primary outcomes:
measure: Mean Change From Baseline in 24-hour Diastolic Ambulatory Blood Pressure Monitoring (ABPM) at Week 4
timeFrame: 24 hour period at Baseline and Week 4
measure: Mean Change From Baseline in 24-hour Systolic Ambulatory Blood Pressure Monitoring (ABPM) at Week 4
timeFrame: 24-hour period at baseline and Week 4
Secondary outcomes:
measure: Mean Change From Baseline in Sitting Diastolic Blood Pressure (siDBP) 24 Hours After Morning Dose at Week 4
timeFrame: Baseline and 24-hours after morning dose at Week 4
measure: Mean Change From Baseline in Sitting Diastolic Blood Pressure (siDBP) After Adding HCTZ 24 Hours After Morning Dose at Week 6
timeFrame: Baseline and 24-hours after morning dose at Week 6
measure: Mean Change From Week 4 in Sitting Diastolic Blood Pressure (siDBP) Adding HCTZ 24 Hours After Morning Dose at Week 6
timeFrame: Baseline and 24-hours after morning dose at Week 6
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Weber MA, Byyny RL, Pratt JH, Faison EP, Snavely DB, Goldberg AI, Nelson EB. Blood pressure effects of the angiotensin II receptor blocker, losartan. Arch Intern Med. 1995 Feb 27;155(4):405-11.