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

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

Intervention: losartan potassium (Drug); Placebo (Drug); Enalapril (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.

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.

Clinical Details

Official title: A Double-Blind, Randomized, Parallel, Placebo-Controlled Study to Investigate the Antihypertensive Efficacy and Safety of Different Doses of DuP 753 (MK0954)

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Mean Change From Baseline in Trough Supine Diastolic Blood Pressure (SuDBP) at Week 8

Secondary outcome:

Categories of Antihypertensive Response in Trough Supine Diastolic Blood Pressure (SuDBP) at Week 8

Mean Change From Baseline in Peak Supine Diastolic Blood Pressure (SuDBP) at Week 8

Eligibility

Minimum age: 21 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Additional Information

Related publications:

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.

Starting date: December 1990
Last updated: July 7, 2009

Page last updated: August 23, 2015

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