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

• Sponsor: Merck Sharp & Dohme LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00856960
• Collaborator: (none)
• Enrollment: 12
• Arms: 4
• Duration (Months): 3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension	Drug: Aliskiren; Drug: Aliskiren; Drug: Comparator: Losartan; Drug: Comparator: Placebo to Aliskiren; Drug: Comparator: Placebo to Losartan	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, 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
• Study Start Date: Jan 1, 2010
• Actual Primary Completion Date: Mar 1, 2010
• Actual Study Completion Date: Apr 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

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 [2-5 hours post dose of study drug]

Secondary Outcome Measures

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 [2-5 hours post dose of study drug]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Locations

No locations specified.

Sponsors and Collaborators

• Merck Sharp & Dohme LLC

Investigators

• Study Director: Medical Monitor, Merck Sharp & Dohme LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Merck Sharp & Dohme LLC
• ClinicalTrials.gov Identifier: NCT00856960
• Other Study ID Numbers: 0000-127; 127; 2009_554
• First Posted: Mar 6, 2009
• Last Update Posted: Jan 22, 2016
• Last Verified: Jan 1, 2016

• Additional relevant MeSH terms: Hypertension; Losartan

Study Results

No Results Posted as of Jan 22, 2016