A Study to Investigate the Magnitude and Duration of Response of MK0954 Compared to Placebo in Patients With Hypertension (0954-021)(COMPLETED)
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
3 other identifiers
interventional
122
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 hypertension
Started May 1991
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 1991
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 1992
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 1992
CompletedFirst Submitted
Initial submission to the registry
April 22, 2009
CompletedFirst Posted
Study publicly available on registry
April 23, 2009
CompletedResults Posted
Study results publicly available
July 14, 2009
CompletedAugust 27, 2015
August 1, 2015
1 year
April 22, 2009
May 21, 2009
August 17, 2015
Conditions
Outcome Measures
Primary Outcomes (2)
Mean Change From Baseline in 24-hour Diastolic Ambulatory Blood Pressure Monitoring (ABPM) at Week 4
24 hour period at Baseline and Week 4
Mean Change From Baseline in 24-hour Systolic Ambulatory Blood Pressure Monitoring (ABPM) at Week 4
24-hour period at baseline and Week 4
Secondary Outcomes (3)
Mean Change From Baseline in Sitting Diastolic Blood Pressure (siDBP) 24 Hours After Morning Dose at Week 4
Baseline and 24-hours after morning dose at Week 4
Mean Change From Baseline in Sitting Diastolic Blood Pressure (siDBP) After Adding HCTZ 24 Hours After Morning Dose at Week 6
Baseline and 24-hours after morning dose at Week 6
Mean Change From Week 4 in Sitting Diastolic Blood Pressure (siDBP) Adding HCTZ 24 Hours After Morning Dose at Week 6
Baseline and 24-hours after morning dose at Week 6
Study Arms (4)
1
PLACEBO COMPARATORPlacebo
2
EXPERIMENTALlosartan 50 mg q.d.
3
EXPERIMENTALlosartan 100 mg q.d.
4
EXPERIMENTALlosartan 50 mg b.i.d.
Interventions
losartan potassium (50 or 100 mg) administered orally once daily (q.d.)or twice daily (b.i.d) for four weeks
placebo capsules to losartan potassium (50 or 100 mg) administered orally once daily (q.d.)or twice daily (b.i.d) for four weeks
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Weber MA, Byyny RL, Pratt JH, Faison EP, Snavely DB, Goldberg AI, Nelson EB. Blood pressure effects of the angiotensin II receptor blocker, losartan. Arch Intern Med. 1995 Feb 27;155(4):405-11.
PMID: 7848024BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Safety has been reported in the literature.
Results Point of Contact
- Title
- Executive Vice President, Clinical and Quantitative Sciences
- Organization
- Merck Sharp & Dohme Corp
Study Officials
- STUDY DIRECTOR
Medical Monitor
Merck Sharp & Dohme LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 22, 2009
First Posted
April 23, 2009
Study Start
May 1, 1991
Primary Completion
May 1, 1992
Study Completion
August 1, 1992
Last Updated
August 27, 2015
Results First Posted
July 14, 2009
Record last verified: 2015-08