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MK0954 Versus Placebo for Treatment of Mild to Moderate Hypertension

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00888355
First received: April 24, 2009
Last updated: July 2, 2009
Last verified: July 2009
History of Changes
  Purpose

The study had a 4 week single blind placebo period followed by 12 weeks of double blind treatment. Patients were randomized to one of four treatment arms to evaluate the antihypertensive efficacy of Losartan.


Condition Intervention Phase
Hypertension
 Drug: losartan potassium
Drug: Comparator: placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomized, Parallel, Placebo-Controlled Study to Investigate the Antihypertensive Efficacy and Safety of Losartan Given Once or Twice Daily in Patients With Mild to Moderate Hypertension

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12 [ Time Frame: At baseline, and at 12 weeks (24 hours after last morning dose and 12 hours after last PM dose) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) as Week 12 [ Time Frame: At baseline, and at 12 weeks (24 hours after last morning dose and 12 hours after last PM dose) ] [ Designated as safety issue: No ]
  • Mean Change From Baseline in Peak Sitting Diastolic Blood Pressure (SiDBP) at Week 12 [ Time Frame: At baseline and at 12 weeks (6 hours after last morning dose) ] [ Designated as safety issue: No ]
  • Categories of Antihypertensive Response in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12 [ Time Frame: 24 hours after last morning dose and 12 hours after last PM dose at 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 428
Study Start Date: May 1992
Study Completion Date: February 1993
Primary Completion Date: January 1993 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Placebo
 Drug: Comparator: placebo
placebo to losartan tablet q.a.m. , for 12 weeks
Experimental: 2
Losartan 50 q.a.m.
 Drug: losartan potassium
losartan tablet (MK0954) 25 or 50 mg q.a.m. or 25 mg b.i.d., for 12 weeks
Other Name: MK0954
Experimental: 3
Losartan 25 b.i.d.
 Drug: losartan potassium
losartan tablet (MK0954) 25 or 50 mg q.a.m. or 25 mg b.i.d., for 12 weeks
Other Name: MK0954
Experimental: 4
Losartan 25 q.a.m.
 Drug: losartan potassium
losartan tablet (MK0954) 25 or 50 mg q.a.m. or 25 mg b.i.d., for 12 weeks
Other Name: MK0954

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient has been diagnosed with mild to moderate hypertension
  • Patient has no treatment or active medical problem, other than hypertension that might affect the patients blood pressure

Exclusion Criteria:

  • Pregnant of lactating female patients
  • Secondary hypertension or history of malignant hypertension
  • Sitting systolic blood pressure > 210 mmHg
  • History of stroke
  • History of myocardial infarction with in the past year
  • Current of prior history of heart failure
  • Known hypersensitivity to losartan
  • Obesity
  • Patients known to be HIV positive or known to be positive for Hepatitis B
  • Absence of one kidney
  • Patient is abusing or previously abused alcohol or drugs with in past two years
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00888355

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

Additional Information:
MedWatch - FDA maintained medical product safety Information  This link exits the ClinicalTrials.gov site
Merck: Patient & Caregiver U.S. Product Web Site  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier: NCT00888355     History of Changes
Other Study ID Numbers: 2009_582, MK0954-065
Study First Received: April 24, 2009
Results First Received: May 7, 2009
Last Updated: July 2, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Losartan
Cardiovascular Agents
 Therapeutic Uses
Pharmacologic Actions
Anti-Arrhythmia Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013