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

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

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

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: Aliskiren; Drug: Aliskiren; Drug: Comparator: Placebo to Losartan; Drug: Comparator: Placebo to Aliskiren; Drug: Comparator: Losartan

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 4; Placebo	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.; 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.
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: 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 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 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: 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 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.; 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.
Active Comparator: 3; Losartan 100 mg	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: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
change in renal plasma flow as measured by PAH clearance and on renal blood flow as measured by ASL MRI after single-dose Aliskiren	2-5 hours post dose of study drug

Secondary Outcome Measures

Outcome Measure	Time Frame
change in renal plasma flow as measured by PAH clearance and on renal blood flow as measured by ASL MRI after single-dose Losartan	2-5 hours post dose of study drug

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): March 1, 2010
• Study Completion (Actual): April 1, 2010

Study Registration Dates

• First Submitted: February 27, 2009
• First Submitted That Met QC Criteria: March 5, 2009
• First Posted (Estimate): March 6, 2009

Study Record Updates

• Last Update Posted (Estimate): January 22, 2016
• Last Update Submitted That Met QC Criteria: January 21, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Losartan
• Other Study ID Numbers: 0000-127; 127 (Tumor Vaccine Group); 2009_554