The Effect of Hypertension Medications on Renal Blood Flow Measurements in Healthy Males - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00856960

Purpose

This study will evaluate the effect of Aliskiren and Losartan on renal blood flow using PAH clearance, PC MRA and ASL MRI methodologies.

Condition	Intervention	Phase
Hypertension	Drug: Aliskiren Drug: Comparator: Losartan Drug: Comparator: Placebo to Aliskiren Drug: Comparator: Placebo to Losartan	Phase I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Pharmacodynamics Study
Official Title:	A Randomized, Double-Blind, Placebo-Controlled, 4-Treatment, 3-Period, Incomplete Block, Balanced Crossover Study to Evaluate the Effects of a Single Dose of Aliskiren and Losartan on Renal Blood Flow Measurements in Healthy Male Subjects

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Losartan Losartan potassium Aliskiren

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

change in renal plasma flow as measured by PAH clearance and on renal blood flow as measured by ASL MRI after single-dose Aliskiren [ Time Frame: 2-5 hours post dose of study drug ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

change in renal plasma flow as measured by PAH clearance and on renal blood flow as measured by ASL MRI after single-dose Losartan [ Time Frame: 2-5 hours post dose of study drug ] [ Designated as safety issue: No ]

Estimated Enrollment:	12
Study Start Date:	January 2010
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Aliskiren 600 mg	Drug: Aliskiren Single dose of four 150 mg tablets (600 mg total) Aliskiren in one of three study periods. There will be at least 10 days between each study period. Drug: Comparator: Placebo to Losartan Single dose of placebo to Losartan 100 mg in one of three study periods. There will be at least 10 days between each study period.
2: Active Comparator Aliskiren 150 mg	Drug: Aliskiren Single dose of one 150 mg tablet of Aliskiren in one of three study periods. There will be at least 10 days between each study period. Drug: Comparator: Placebo to Aliskiren Three or four tablets placebo to Aliskiren 150 mg in one of three study periods. There will be at least 10 days between each study period. Drug: Comparator: Placebo to Losartan Single dose of placebo to Losartan 100 mg in one of three study periods. There will be at least 10 days between each study period.
3: Active Comparator Losartan 100 mg	Drug: Comparator: Losartan Single dose of one 100 mg tablet Losartan in one of three study periods. There will be at least 10 days between each study period. Drug: Comparator: Placebo to Aliskiren Three or four tablets placebo to Aliskiren 150 mg in one of three study periods. There will be at least 10 days between each study period.
4: Placebo Comparator Placebo	Drug: Comparator: Placebo to Aliskiren Three or four tablets placebo to Aliskiren 150 mg in one of three study periods. There will be at least 10 days between each study period. Drug: Comparator: Placebo to Losartan Single dose of placebo to Losartan 100 mg in one of three study periods. There will be at least 10 days between each study period.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Subject is in generally good health
Subject is willing to avoid unaccustomed strenuous exercise during the study
Subject agrees to consume ONLY the study-specified diet during all domiciled periods
Subject has been a non-smoker for at least 3 months prior to study
Subject will refrain from smoking or using any tobacco products during the study
Subject agrees to refrain from consuming alcohol or caffeine during the domiciled periods and agrees to limit alcohol and caffeine consumption throughout the study

Exclusion Criteria:

Subject has contraindication to MRI scans
Subject has a history of stroke, seizure, or major neurological disorders
Subject uses illicit drugs or has a history of drug/alcohol abuse
Subject has had major surgery, has donated or lost 1 unit of blood, or has been in another investigational study in the last 4 weeks
Subject has a history of multiple and/or severe allergies to drugs or food

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00856960

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2009_554, 127
Study First Received:	February 27, 2009
Last Updated:	September 2, 2009
ClinicalTrials.gov Identifier:	NCT00856960 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

Healthy
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 September 10, 2009