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

Organon and Co13 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

DOUBLE

Enrollment

Conditions

Hypertension

Interventions

losartan potassiumDRUG

Single dose losartan 100 mg in one of five treatment periods

Comparator: isosorbide mononitrate (ISMN)DRUG

Single dose ISMN 60 mg in one of five treatment periods

Comparator: losartan + ISMNDRUG

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

Eligibility

Sex: ALLMin age: 45 YearsMax age: 70 Years

Medical Language ↔ Plain English

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®

Outcomes

Primary Outcomes

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

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.

Time frame: Baseline and 10 hours postdose

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

Data from ClinicalTrials.gov

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