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

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00886600

Purpose

The purpose of this study was to evaluate the magnitude and durations of the antihypertensive effects of losartan using ambulatory blood pressure monitoring, 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	Phase III

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Losartan Losartan potassium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
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

Further study details as provided by Merck:

Primary Outcome Measures:

Mean change from baseline in 24-hour diastolic ambulatory blood pressure monitoring (ABPM) at Week 4 [ Time Frame: 24 hours period at 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 hours period at 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: 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: 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: 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
1: Placebo Comparator Placebo	Drug: Comparator: placebo two placebo capsules to MK0954 administered twice daily for four weeks
2: Experimental MK0954 50 mg QD	Drug: losartan potassium two capsules (50 or 100 mg) administered twice daily for four weeks
3: Experimental MK0954 100 mg QD	Drug: losartan potassium two capsules (50 or 100 mg) administered twice daily for four weeks
4: Experimental MK0954 50 mg BID	Drug: losartan potassium two capsules (50 or 100 mg) administered twice daily for four weeks

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

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

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

PhRMA Clinical Study Results Database - web-based repository for clinical study results 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:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2009_581, MK0954-021
Study First Received:	April 22, 2009
Last Updated:	April 22, 2009
ClinicalTrials.gov Identifier:	NCT00886600 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Angiotensin II Type 1 Receptor Blockers
Losartan
Vascular Diseases
Cardiovascular Agents

Anti-Arrhythmia Agents
Angiotensin II
Antihypertensive Agents
Hypertension

Additional relevant MeSH terms:

Angiotensin II Type 1 Receptor Blockers
Losartan
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Vascular Diseases
Cardiovascular Diseases

Cardiovascular Agents
Anti-Arrhythmia Agents
Antihypertensive Agents
Pharmacologic Actions
Hypertension

ClinicalTrials.gov processed this record on May 07, 2009