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MK0954 Versus Placebo for Treatment of Mild to Moderate Hypertension

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ClinicalTrials.gov Identifier: NCT00888355
Recruitment Status : Completed
First Posted : April 27, 2009
Results First Posted : June 24, 2009
Last Update Posted : July 9, 2009
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.

Brief Summary:
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 or disease Intervention/treatment Phase
Hypertension Drug: losartan potassium Drug: Comparator: placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 428 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : May 1992
Actual Primary Completion Date : January 1993
Actual Study Completion Date : February 1993

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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) ]

Secondary Outcome Measures :
  1. 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) ]
  2. 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) ]
  3. 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 ]


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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00888355


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.

Additional Information:
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
First Posted: April 27, 2009    Key Record Dates
Results First Posted: June 24, 2009
Last Update Posted: July 9, 2009
Last Verified: July 2009

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