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Completed

NCT Number: NCT00856960

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

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

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aliskiren

Drug

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.

Comparator: losartan

Drug

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.

Comparator: Placebo to Aliskiren

Drug

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.

Comparator: Placebo to Losartan

Drug

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Mar 6, 2009
Registry last updated
Jan 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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