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

Phase 1

Completed

• Conditions: Hypertension
• Interventions: Drug: losartan potassium

• Registration Number: NCT00943852
• Lead Sponsor: Organon and Co

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08
• Primary Completion: 2006-12
• Study Completion: 2006-12
• Study First Submitted: 2009-07-21
• Study First Submitted QC: 2009-07-21
• Study First Posted: 2009-07-22
• Results First Submitted: 2010-04-27
• Results First Submitted QC: 2010-06-21
• Results First Posted: 2010-07-15
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-07
• Last Update Posted: 2022-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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®

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	losartan potassium	losartan 100 mg

Primary Outcome Measures

Name	Time	Method
Mean Augmentation Index Percent Change From Baseline After Single Doses of Losartan 100 mg + ISMN 60 mg Versus Single Dose of Placebo	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.
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	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.