The Effect of Hypertension Medications on Renal Blood Flow Measurements in Healthy Males
Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: Aliskiren (Drug); Aliskiren (Drug); Comparator: Losartan (Drug); Comparator: Placebo to Aliskiren (Drug); Comparator: Placebo to Losartan (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Merck Sharp & Dohme Corp. Official(s) and/or principal investigator(s): Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.
Summary
This study will evaluate the effect of Aliskiren and Losartan on renal blood flow using PAH
clearance, PC MRA and ASL MRI methodologies.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: change in renal plasma flow as measured by PAH clearance and on renal blood flow as measured by ASL MRI after single-dose Aliskiren
Secondary outcome: change in renal plasma flow as measured by PAH clearance and on renal blood flow as measured by ASL MRI after single-dose Losartan
Eligibility
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Male.
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
Locations and Contacts
Additional Information
Starting date: January 2010
Last updated: April 2, 2010
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