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The Effect of Hypertension Medications on Renal Blood Flow Measurements in Healthy Males

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00856960
First received: February 27, 2009
Last updated: April 2, 2010
Last verified: April 2010
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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:


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

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 ]

Enrollment: 12
Study Start Date: January 2010
Study Completion Date: April 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
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.
Active Comparator: 2
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.
Active Comparator: 3
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.
Placebo Comparator: 4
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
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: NCT00856960

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

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00856960     History of Changes
Other Study ID Numbers: 2009_554, 127
Study First Received: February 27, 2009
Last Updated: April 2, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases
Losartan
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Anti-Arrhythmia Agents
Antihypertensive Agents
Cardiovascular Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014