The Effect of Losartan and Losartan Plus Isosorbide Mononitrate on Central Blood Pressure Measurements (0954-317)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00943852
First received: July 21, 2009
Last updated: March 31, 2014
Last verified: March 2014
  Purpose

This study will qualify a functional model that can measure central blood pressure and vascular compliance effects through noninvasive means.


Condition Intervention Phase
Hypertension
Drug: losartan potassium
Drug: Comparator: isosorbide mononitrate (ISMN)
Drug: Comparator: losartan + ISMN
Drug: Comparator: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Diagnostic
Official Title: A Double-Blind, Randomized, Placebo-Controlled, 5-Period Crossover Study to Evaluate the Effects of a Single Dose of Losartan, a Single Dose of Isosorbide Mononitrate (ISMN), and Single Doses of Losartan + ISMN on Central Blood Pressure Measurements in Mildly Hypertensive Patients

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Mean Augmentation Index Percent Change From Baseline After Single Doses of Losartan 100 mg Plus ISMN 60 mg Versus Single Dose of Losartan 100 mg [ Time Frame: Baseline and 10 hours postdose ] [ Designated as safety issue: No ]
    The augmentation index (AIx) is defined as the ratio of augmentation (Δ P) to central pulse pressure and expressed as percent. AIx = (ΔP/PP) x 100, where P = pressure and PP = Pulse Pressure. A mathematical transfer function translated the peripheral wave form into a central waveform using an FDA approved process based on directly recorded arterial pressure values. The mean AIx for each subject was estimated as a time-weighted average over the 10-hour post dose observation period and expressed as a change from baseline.

  • Mean Augmentation Index Percent Change From Baseline After Single Doses of Losartan 100 mg + ISMN 60 mg Versus Single Dose of Placebo [ Time Frame: Baseline and 10 hours postdose ] [ Designated as safety issue: No ]

    The augmentation index (AIx) is defined as the ratio of augmentation (Δ P) to central pulse pressure and expressed as percent. AIx = (ΔP/PP) x 100, where P =

    pressure and PP = Pulse Pressure. A mathematical transfer function translated the peripheral wave form into a central waveform using an FDA approved process based on directly recorded arterial pressure values. The mean AIx for each subject was estimated as a time-weighted average over the 10-hour post dose observation period and expressed as a change from baseline.



Enrollment: 13
Study Start Date: August 2006
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
losartan 100 mg
Drug: losartan potassium
Single dose losartan 100 mg in one of five treatment periods
Other Name: COZAAR
Active Comparator: 2
ISMN 60 mg
Drug: Comparator: isosorbide mononitrate (ISMN)
Single dose ISMN 60 mg in one of five treatment periods
Other Name: IMDUR
Active Comparator: 3
losartan 100 mg + ISMN 15 mg
Drug: Comparator: losartan + ISMN
Single dose losartan 100 mg and ISMN 15 mg in one of five treatment periods
Active Comparator: 4
losartan 100 mg + ISMN 60 mg
Drug: Comparator: losartan + ISMN
Single dose losartan 100 mg and ISMN 60 mg in one of five treatment periods
Placebo Comparator: 5
Placebo
Drug: Comparator: Placebo
Single dose placebo only in one of five treatment periods

  Eligibility

Ages Eligible for Study:   45 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient is in good health with the exception of mild to moderate hypertension
  • Patient is willing to comply with the study restrictions
  • Patient does not smoke

Exclusion Criteria:

  • Patient has a history of any illness that might confound the results of the study or make participation in the study unsafe
  • Patient is taking a prescription medication that is contraindicated for use with COZAAR® or IMDUR®
  • Patient has a condition for which there is a warning, contraindication, or precaution against the use of COZAAR® or IMDUR®
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00943852

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

Additional Information:
Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00943852     History of Changes
Other Study ID Numbers: 0954-317, MK0954-317, 2009_610
Study First Received: July 21, 2009
Results First Received: April 27, 2010
Last Updated: March 31, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases
Isosorbide
Isosorbide Dinitrate
Isosorbide-5-mononitrate
Losartan
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Anti-Arrhythmia Agents
Antihypertensive Agents
Cardiovascular Agents
Diuretics
Diuretics, Osmotic
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Nitric Oxide Donors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on October 23, 2014