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OpenTrials
Completed

NCT Number: NCT00943852

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

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

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

45 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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®

Treatment and study plan

Losartan Potassium

Drug

Single dose losartan 100 mg in one of five treatment periods

Other names: COZAAR

Comparator: isosorbide mononitrate (ISMN)

Drug

Single dose ISMN 60 mg in one of five treatment periods

Other names: IMDUR

Comparator: losartan + ISMN

Drug

Single dose losartan 100 mg and ISMN 15 mg in one of five treatment periods

Comparator: placebo

Drug

Single dose placebo only in one of five treatment periods

Primary outcomes

  1. 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

    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.

  2. 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

    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.

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2006
Study completion
2006
First posted
Jul 22, 2009
Registry last updated
Feb 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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