A Study to Investigate the Antihypertensive Efficacy of MK0954

NCT ID: NCT00887250

Last Updated: 2009-07-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 366 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1991-12-31
• Study Completion Date: 1992-11-30

Brief Summary

After a 4 week placebo period, patients were randomized to Placebo or Losartan 50 mg arms, after 6 weeks non-responders were up titrated to 100 mg losartan for the remaining 6 weeks. This study evaluated if losartan is more effective than placebo in lowering sitting diastolic blood pressure and is well tolerated in patients with mild to moderate hypertension.

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 to Losartan

2

Losartan 50 mg for 12 weeks

Group Type: EXPERIMENTAL

losartan potassium

Intervention Type: DRUG

50 mg Losartan (MK0954) tablet taken once daily for 12 weeks.

3

Losartan 50 mg titrated to 100 mg after 6 weeks

Group Type: EXPERIMENTAL

Comparator: losartan

Intervention Type: DRUG

50 mg tablet of Losartan (MK0954) taken once daily for 6 weeks, Non-responders will then have the dose up titrated to 100 mg for remaining 6 weeks.

Interventions

losartan potassium

50 mg Losartan (MK0954) tablet taken once daily for 12 weeks.

Intervention Type: DRUG

Comparator: losartan

50 mg tablet of Losartan (MK0954) taken once daily for 6 weeks, Non-responders will then have the dose up titrated to 100 mg for remaining 6 weeks.

Intervention Type: DRUG

Comparator: Placebo

Placebo to Losartan

Intervention Type: DRUG

Other Intervention Names

MK0954; MK0954

Eligibility Criteria

Inclusion Criteria

• Patient has been diagnosed with mild to moderate hypertension (SDBP 95-115 mm Hg)
• Patient has no medical problems or treatments that might effect their blood pressure

Exclusion Criteria

• Pregnant or lactating females
• Patient has secondary hypertension or malignant hypertension
• Sitting systolic blood pressure > 210 mm Hg
• History of stroke
• History of myocardial infarction with in past year
• Current or prior history of heart failure
• Known hypersensitivity to losartan
• Prior exposure to losartan
• Patients known to be HIV positive
• Patient is abusing or has abused alcohol or other drugs within the past 4 years

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

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Merck & Co., Inc.

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Other Identifiers

MK0954-050

Identifier Type: -

Identifier Source: secondary_id

2009_580

Identifier Type: -

Identifier Source: org_study_id