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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00856960
First Posted: March 6, 2009
Last Update Posted: January 22, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  Purpose
This study will evaluate the effect of Aliskiren and Losartan on renal blood flow using PAH clearance, PC MRA and ASL MRI methodologies.

Condition Intervention Phase
Hypertension Drug: Aliskiren Drug: Comparator: Losartan Drug: Comparator: Placebo to Aliskiren Drug: Comparator: Placebo to Losartan Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • change in renal plasma flow as measured by PAH clearance and on renal blood flow as measured by ASL MRI after single-dose Aliskiren [ Time Frame: 2-5 hours post dose of study drug ]

Secondary Outcome Measures:
  • change in renal plasma flow as measured by PAH clearance and on renal blood flow as measured by ASL MRI after single-dose Losartan [ Time Frame: 2-5 hours post dose of study drug ]

Enrollment: 12
Study Start Date: January 2010
Study Completion Date: April 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00856960


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00856960     History of Changes
Other Study ID Numbers: 0000-127
127
2009_554
First Submitted: February 27, 2009
First Posted: March 6, 2009
Last Update Posted: January 22, 2016
Last Verified: January 2016

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Losartan
Anti-Arrhythmia Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action