A Study to Investigate the Magnitude and Duration of Response of MK0954 Compared to Placebo in Patients With Hypertension

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00886600
First received: April 22, 2009
Last updated: July 27, 2009
Last verified: July 2009
  Purpose

The purpose of this study was to evaluate the magnitude and durations of the antihypertensive effects of losartan using ambulatory blood pressure monitoring (ABPM), and to evaluate the safety of losartan 50 and 100 mg doses compared to placebo.


Condition Intervention Phase
Hypertension
Drug: losartan potassium
Drug: Comparator: placebo
Drug: hydrochlorothiazide (HCTZ)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Double-blind, Randomized, Parallel-group, Placebo-controlled Pilot Study to Investigate the Magnitude and Duration of Response and the Safety of MK0954 (50 mg Given Once or Twice Daily, or 100 mg Given Once Daily) Compared to Placebo Using Ambulatory Blood Pressure Monitoring

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Mean Change From Baseline in 24-hour Diastolic Ambulatory Blood Pressure Monitoring (ABPM) at Week 4 [ Time Frame: 24 hour period at Baseline and Week 4 ] [ Designated as safety issue: No ]
  • Mean Change From Baseline in 24-hour Systolic Ambulatory Blood Pressure Monitoring (ABPM) at Week 4 [ Time Frame: 24-hour period at baseline and Week 4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean Change From Baseline in Sitting Diastolic Blood Pressure (siDBP) 24 Hours After Morning Dose at Week 4 [ Time Frame: Baseline and 24-hours after morning dose at Week 4 ] [ Designated as safety issue: No ]
  • Mean Change From Baseline in Sitting Diastolic Blood Pressure (siDBP) After Adding HCTZ 24 Hours After Morning Dose at Week 6 [ Time Frame: Baseline and 24-hours after morning dose at Week 6 ] [ Designated as safety issue: No ]
  • Mean Change From Week 4 in Sitting Diastolic Blood Pressure (siDBP) Adding HCTZ 24 Hours After Morning Dose at Week 6 [ Time Frame: Baseline and 24-hours after morning dose at Week 6 ] [ Designated as safety issue: No ]

Enrollment: 122
Study Start Date: May 1991
Study Completion Date: August 1992
Primary Completion Date: May 1992 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Placebo
Drug: Comparator: placebo
placebo capsules to losartan potassium (50 or 100 mg) administered orally once daily (q.d.)or twice daily (b.i.d) for four weeks
Drug: hydrochlorothiazide (HCTZ)
open-label hydrochlorothiazide (HCTZ) 12.5 mg (for patients with Sitting Diastolic Blood Pressure (SiDBP) ≥85 mm Hg after 4 weeks of losartan monotherapy (Combination Therapy Period)) orally once daily (q.d.) for 2 weeks
Other Name: HCTZ
Experimental: 2
losartan 50 mg q.d.
Drug: losartan potassium
losartan potassium (50 or 100 mg) administered orally once daily (q.d.)or twice daily (b.i.d) for four weeks
Other Name: MK0954
Drug: hydrochlorothiazide (HCTZ)
open-label hydrochlorothiazide (HCTZ) 12.5 mg (for patients with Sitting Diastolic Blood Pressure (SiDBP) ≥85 mm Hg after 4 weeks of losartan monotherapy (Combination Therapy Period)) orally once daily (q.d.) for 2 weeks
Other Name: HCTZ
Experimental: 3
losartan 100 mg q.d.
Drug: losartan potassium
losartan potassium (50 or 100 mg) administered orally once daily (q.d.)or twice daily (b.i.d) for four weeks
Other Name: MK0954
Drug: hydrochlorothiazide (HCTZ)
open-label hydrochlorothiazide (HCTZ) 12.5 mg (for patients with Sitting Diastolic Blood Pressure (SiDBP) ≥85 mm Hg after 4 weeks of losartan monotherapy (Combination Therapy Period)) orally once daily (q.d.) for 2 weeks
Other Name: HCTZ
Experimental: 4
losartan 50 mg b.i.d.
Drug: losartan potassium
losartan potassium (50 or 100 mg) administered orally once daily (q.d.)or twice daily (b.i.d) for four weeks
Other Name: MK0954
Drug: hydrochlorothiazide (HCTZ)
open-label hydrochlorothiazide (HCTZ) 12.5 mg (for patients with Sitting Diastolic Blood Pressure (SiDBP) ≥85 mm Hg after 4 weeks of losartan monotherapy (Combination Therapy Period)) orally once daily (q.d.) for 2 weeks
Other Name: HCTZ

  Eligibility

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

Inclusion Criteria:

  • Non-black men and women with mild to moderate hypertension and within 30% of their ideal body weight
  • Patient is in good general health
  • Blood pressure at time of randomization is 95-115 mm Hg

Exclusion Criteria:

  • Secondary Hypertension or history of malignant hypertension
  • History of stroke
  • History of myocardial infarction
  • Atrial flutter or atrial fibrillation
  • History of congestive Heart failure
  • Patient taking major psychotropic agent or anti-depressant
  • Patient regularly uses NSAIDS or high dose aspirin
  • Known positive test for HIV/AIDS or Hepatitis B
  • Patient is being treated for acute ulcer disease
  • Prior exposure to losartan
  • Actively treated diabetes mellitus
  • History of chronic liver disease
  • Actively treated diabetes mellitus
  • Any known bleeding or platelet disorder
  • Absence of one kidney
  • Women of childbearing potential
  • Alcoholism or drug addiction
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00886600

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

Additional Information:
Publications:
Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier: NCT00886600     History of Changes
Other Study ID Numbers: 2009_581, MK0954-021
Study First Received: April 22, 2009
Results First Received: May 21, 2009
Last Updated: July 27, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Hydrochlorothiazide
Losartan
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Arrhythmia Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on September 16, 2014