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A Study to Investigate the Magnitude and Duration of Response of MK0954 Compared to Placebo in Patients With Hypertension (0954-021)(COMPLETED)

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ClinicalTrials.gov Identifier: NCT00886600
Recruitment Status : Completed
First Posted : April 23, 2009
Results First Posted : July 14, 2009
Last Update Posted : August 27, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 122 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : May 1991
Actual Primary Completion Date : May 1992
Actual Study Completion Date : August 1992

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 ]
  2. 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 ]

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


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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:

  • 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

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): NCT00886600


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

Additional Information:
Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00886600     History of Changes
Other Study ID Numbers: 0954-021
MK0954-021
2009_581
First Posted: April 23, 2009    Key Record Dates
Results First Posted: July 14, 2009
Last Update Posted: August 27, 2015
Last Verified: August 2015

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