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

NCT00856960 | Completed Phase 1

• 3 other identifiers: 0000-1271272009_554
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hypertension

Outcome Measures

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

  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

  2-5 hours post dose of study drug

Study Arms (4)

1

ACTIVE COMPARATOR

Aliskiren 600 mg

Drug: Aliskiren; Drug: Comparator: Placebo to Losartan

2

ACTIVE COMPARATOR

Aliskiren 150 mg

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

3

ACTIVE COMPARATOR

Losartan 100 mg

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

4

PLACEBO COMPARATOR

Placebo

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

Interventions

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.

1

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.

3

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.

2; 3; 4

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.

1; 2; 4

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Hypertension

Interventions

aliskiren

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2009
• First Posted: March 6, 2009
• Study Start: January 1, 2010
• Primary Completion: March 1, 2010
• Study Completion: April 1, 2010
• Last Updated: January 22, 2016

Record last verified: 2016-01