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The Effect of Hypertension Medications on Renal Blood Flow Measurements in Healthy Males (MK-0000-127)

Phase 1
Completed
Conditions
Hypertension
Interventions
Registration Number
NCT00856960
Lead Sponsor
Merck Sharp & Dohme LLC
Brief Summary

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

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
Male
Target Recruitment
12
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
1AliskirenAliskiren 600 mg
2AliskirenAliskiren 150 mg
Primary Outcome Measures
NameTimeMethod
change in renal plasma flow as measured by PAH clearance and on renal blood flow as measured by ASL MRI after single-dose Aliskiren2-5 hours post dose of study drug
Secondary Outcome Measures
NameTimeMethod
change in renal plasma flow as measured by PAH clearance and on renal blood flow as measured by ASL MRI after single-dose Losartan2-5 hours post dose of study drug
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