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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

Page last updated: August 20, 2015

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