A Study to Investigate the Efficacy and Safety of Different Doses of Losartan Potassium (MK0954-011)

NCT ID: NCT00882440

Last Updated: 2015-08-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 576 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1990-12-31
• Study Completion Date: 1992-01-31

Brief Summary

The purpose of this study was to compare the antihypertensive efficacy of different doses of losartan compared to placebo and enalapril, in patients with supine diastolic blood pressure of 100-115 mmHg.

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

Placebo

Intervention Type: DRUG

Placebo capsule to losartan

2

Losartan 10 mg

Group Type: EXPERIMENTAL

losartan potassium

Intervention Type: DRUG

losartan oral capsule (10, 25, 50, 100 or 150 mg) once daily for 8 weeks

3

Losartan 25 mg

Group Type: EXPERIMENTAL

losartan potassium

Intervention Type: DRUG

losartan oral capsule (10, 25, 50, 100 or 150 mg) once daily for 8 weeks

4

Losartan 50 mg

Group Type: EXPERIMENTAL

losartan potassium

Intervention Type: DRUG

losartan oral capsule (10, 25, 50, 100 or 150 mg) once daily for 8 weeks

5

Losartan 100 mg

Group Type: EXPERIMENTAL

losartan potassium

Intervention Type: DRUG

losartan oral capsule (10, 25, 50, 100 or 150 mg) once daily for 8 weeks

6

Losartan 150 mg

Group Type: EXPERIMENTAL

losartan potassium

Intervention Type: DRUG

losartan oral capsule (10, 25, 50, 100 or 150 mg) once daily for 8 weeks

7

Enalapril 20 mg

Group Type: ACTIVE_COMPARATOR

Enalapril

Intervention Type: DRUG

Enalapril 20 mg oral tablet taken once daily for 8 weeks

Interventions

losartan potassium

losartan oral capsule (10, 25, 50, 100 or 150 mg) once daily for 8 weeks

Intervention Type: DRUG

Placebo

Placebo capsule to losartan

Intervention Type: DRUG

Enalapril

Enalapril 20 mg oral tablet taken once daily for 8 weeks

Intervention Type: DRUG

Other Intervention Names

MK0954; Cozaar

Eligibility Criteria

Inclusion Criteria

• Patient has been diagnosed with mild to moderate hypertension, with supine diastolic blood pressure of 100 to 115 mmHg
• Patient has no active medical problems other than essential hypertension that might affect blood pressure
• Patient has received no drug therapy that might affect blood pressure

Exclusion Criteria

• Prior exposure to losartan
• History of stroke
• History of myocardial infarction
• Atrial flutter or atrial fibrillation
• History of congestive Heart failure
• Known Sensitivity to ACE inhibitors
• Known positive test for HIV/AIDS or Hepatitis B
• Patient is being treated for acute ulcer disease
• History of chronic liver disease
• Actively treated diabetes mellitis
• Any known bleeding or platelet disorder
• Absence of one kidney
• Women of childbearing potential or who are breastfeeding
• Patient is abusing or has a history of 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

Gradman AH, Arcuri KE, Goldberg AI, Ikeda LS, Nelson EB, Snavely DB, Sweet CS. A randomized, placebo-controlled, double-blind, parallel study of various doses of losartan potassium compared with enalapril maleate in patients with essential hypertension. Hypertension. 1995 Jun;25(6):1345-50. doi: 10.1161/01.hyp.25.6.1345.

Reference Type: BACKGROUND

PMID: 7768585 (View on PubMed)

Other Identifiers

MK0954-011

Identifier Type: -

Identifier Source: secondary_id

2009_574

Identifier Type: -

Identifier Source: secondary_id

0954-011

Identifier Type: -

Identifier Source: org_study_id