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

NCT ID: NCT00886600

Last Updated: 2015-08-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 122 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1991-05-31
• Study Completion Date: 1992-08-31

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.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

Placebo

Group Type: PLACEBO_COMPARATOR

Comparator: placebo

Intervention Type: DRUG

placebo capsules to losartan potassium (50 or 100 mg) administered orally once daily (q.d.)or twice daily (b.i.d) for four weeks

hydrochlorothiazide (HCTZ)

Intervention Type: DRUG

open-label hydrochlorothiazide (HCTZ) 12.5 mg (for patients with Sitting Diastolic Blood Pressure (SiDBP) ≥85 mm Hg after 4 weeks of losartan monotherapy (Combination Therapy Period)) orally once daily (q.d.) for 2 weeks

2

losartan 50 mg q.d.

Group Type: EXPERIMENTAL

losartan potassium

Intervention Type: DRUG

losartan potassium (50 or 100 mg) administered orally once daily (q.d.)or twice daily (b.i.d) for four weeks

hydrochlorothiazide (HCTZ)

Intervention Type: DRUG

open-label hydrochlorothiazide (HCTZ) 12.5 mg (for patients with Sitting Diastolic Blood Pressure (SiDBP) ≥85 mm Hg after 4 weeks of losartan monotherapy (Combination Therapy Period)) orally once daily (q.d.) for 2 weeks

3

losartan 100 mg q.d.

Group Type: EXPERIMENTAL

losartan potassium

Intervention Type: DRUG

losartan potassium (50 or 100 mg) administered orally once daily (q.d.)or twice daily (b.i.d) for four weeks

hydrochlorothiazide (HCTZ)

Intervention Type: DRUG

open-label hydrochlorothiazide (HCTZ) 12.5 mg (for patients with Sitting Diastolic Blood Pressure (SiDBP) ≥85 mm Hg after 4 weeks of losartan monotherapy (Combination Therapy Period)) orally once daily (q.d.) for 2 weeks

4

losartan 50 mg b.i.d.

Group Type: EXPERIMENTAL

losartan potassium

Intervention Type: DRUG

losartan potassium (50 or 100 mg) administered orally once daily (q.d.)or twice daily (b.i.d) for four weeks

hydrochlorothiazide (HCTZ)

Intervention Type: DRUG

open-label hydrochlorothiazide (HCTZ) 12.5 mg (for patients with Sitting Diastolic Blood Pressure (SiDBP) ≥85 mm Hg after 4 weeks of losartan monotherapy (Combination Therapy Period)) orally once daily (q.d.) for 2 weeks

Interventions

losartan potassium

losartan potassium (50 or 100 mg) administered orally once daily (q.d.)or twice daily (b.i.d) for four weeks

Intervention Type: DRUG

Comparator: placebo

placebo capsules to losartan potassium (50 or 100 mg) administered orally once daily (q.d.)or twice daily (b.i.d) for four weeks

Intervention Type: DRUG

hydrochlorothiazide (HCTZ)

open-label hydrochlorothiazide (HCTZ) 12.5 mg (for patients with Sitting Diastolic Blood Pressure (SiDBP) ≥85 mm Hg after 4 weeks of losartan monotherapy (Combination Therapy Period)) orally once daily (q.d.) for 2 weeks

Intervention Type: DRUG

Other Intervention Names

MK0954; HCTZ

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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.

Reference Type: BACKGROUND

PMID: 7848024 (View on PubMed)

Other Identifiers

MK0954-021

Identifier Type: -

Identifier Source: secondary_id

2009_581

Identifier Type: -

Identifier Source: secondary_id

0954-021

Identifier Type: -

Identifier Source: org_study_id