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The Effect of Losartan and Losartan Plus Isosorbide Mononitrate on Central Blood Pressure Measurements

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00943852
First received: July 21, 2009
Last updated: June 21, 2010
Last verified: June 2010
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Merck:

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: January 2007
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00943852

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

Additional Information:
MedWatch - FDA maintained medical product safety Information  This link exits the ClinicalTrials.gov site
Merck: Patient & Caregiver U.S. Product Web Site  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00943852     History of Changes
Other Study ID Numbers: 2009_610, MK0954-317
Study First Received: July 21, 2009
Results First Received: April 27, 2010
Last Updated: June 21, 2010
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 16, 2013