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

NCT ID: NCT00856960

Last Updated: 2016-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-04-30

Brief Summary

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

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Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Aliskiren 600 mg

Group Type ACTIVE_COMPARATOR

Aliskiren

Intervention Type 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.

Comparator: Placebo to Losartan

Intervention Type 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.

2

Aliskiren 150 mg

Group Type ACTIVE_COMPARATOR

Aliskiren

Intervention Type DRUG

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.

Comparator: Placebo to Aliskiren

Intervention Type 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.

Comparator: Placebo to Losartan

Intervention Type 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.

3

Losartan 100 mg

Group Type ACTIVE_COMPARATOR

Comparator: Losartan

Intervention Type 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.

Comparator: Placebo to Aliskiren

Intervention Type 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.

4

Placebo

Group Type PLACEBO_COMPARATOR

Comparator: Placebo to Aliskiren

Intervention Type 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.

Comparator: Placebo to Losartan

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Other Identifiers

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127

Identifier Type: -

Identifier Source: secondary_id

2009_554

Identifier Type: -

Identifier Source: secondary_id

0000-127

Identifier Type: -

Identifier Source: org_study_id

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