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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Hypertension

Treatments: Drug: Comparator: Losartan; Drug: Comparator: Placebo to Aliskiren; Drug: Aliskiren; Drug: Comparator: Placebo to Losartan

Study type: Interventional

Funder types: Industry

Identifiers

NCT00856960

0000-127

2009_554

127

Details and patient eligibility

About

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

Enrollment: 12 patients

Sex: Male

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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12 participants in 4 patient groups, including a placebo group

1

Active Comparator group

Description:

Aliskiren 600 mg

Treatment:

Drug: Aliskiren

Drug: Aliskiren

Drug: Comparator: Placebo to Losartan

2

Active Comparator group

Description:

Aliskiren 150 mg

Treatment:

Drug: Comparator: Placebo to Aliskiren

Drug: Aliskiren

Drug: Aliskiren

Drug: Comparator: Placebo to Losartan

3

Active Comparator group

Description:

Losartan 100 mg

Treatment:

Drug: Comparator: Losartan

Drug: Comparator: Placebo to Aliskiren

4

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Comparator: Placebo to Aliskiren

Drug: Comparator: Placebo to Losartan