A Study to Investigate the Magnitude and Duration of Response of MK0954 Compared to Placebo in Patients With Hypertension (0954-021)(COMPLETED)

Phase 3

Completed

• Conditions: Hypertension
• Interventions: Drug: losartan potassium; Drug: hydrochlorothiazide (HCTZ)

• Registration Number: NCT00886600
• Lead Sponsor: Merck Sharp & Dohme LLC

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.

Detailed Description

Not available

Study Timeline

• Study Start: 1991-05
• Primary Completion: 1992-05
• Study Completion: 1992-08
• Study First Submitted: 2009-04-22
• Study First Submitted QC: 2009-04-22
• Study First Posted: 2009-04-23
• Results First Submitted: 2009-05-21
• Results First Submitted QC: 2009-05-21
• Results First Posted: 2009-07-14
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-17
• Last Update Posted: 2015-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
4	hydrochlorothiazide (HCTZ)	losartan 50 mg b.i.d.
3	hydrochlorothiazide (HCTZ)	losartan 100 mg q.d.
1	hydrochlorothiazide (HCTZ)	Placebo
2	losartan potassium	losartan 50 mg q.d.
2	hydrochlorothiazide (HCTZ)	losartan 50 mg q.d.
3	losartan potassium	losartan 100 mg q.d.
4	losartan potassium	losartan 50 mg b.i.d.

Primary Outcome Measures

Name	Time	Method
Mean Change From Baseline in 24-hour Diastolic Ambulatory Blood Pressure Monitoring (ABPM) at Week 4	24 hour period at Baseline and Week 4
Mean Change From Baseline in 24-hour Systolic Ambulatory Blood Pressure Monitoring (ABPM) at Week 4	24-hour period at baseline and Week 4

Secondary Outcome Measures

Name	Time	Method
Mean Change From Week 4 in Sitting Diastolic Blood Pressure (siDBP) Adding HCTZ 24 Hours After Morning Dose at Week 6	Baseline and 24-hours after morning dose at Week 6
Mean Change From Baseline in Sitting Diastolic Blood Pressure (siDBP) 24 Hours After Morning Dose at Week 4	Baseline and 24-hours after morning dose at Week 4
Mean Change From Baseline in Sitting Diastolic Blood Pressure (siDBP) After Adding HCTZ 24 Hours After Morning Dose at Week 6	Baseline and 24-hours after morning dose at Week 6