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

Merck Sharp & Dohme (MSD) logo

Merck Sharp & Dohme (MSD)

Status and phase

Completed
Phase 1

Conditions

Hypertension

Treatments

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

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

12 participants in 4 patient groups, including a placebo group

1
Active Comparator group
Description:
Aliskiren 600 mg
Treatment:
Drug: Aliskiren
Drug: Comparator: Placebo to Losartan
2
Active Comparator group
Description:
Aliskiren 150 mg
Treatment:
Drug: Comparator: Placebo to Aliskiren
Drug: Aliskiren
Drug: Comparator: Placebo to Losartan
3
Active Comparator group
Description:
Losartan 100 mg
Treatment:
Drug: Comparator: Placebo to Aliskiren
Drug: Comparator: Losartan
4
Placebo Comparator group
Description:
Placebo
Treatment:
Drug: Comparator: Placebo to Aliskiren
Drug: Comparator: Placebo to Losartan

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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