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
Overview
- Phase
- Phase 1
- Intervention
- losartan potassium
- Conditions
- Hypertension
- Sponsor
- Organon and Co
- Enrollment
- 13
- Primary Endpoint
- Mean Augmentation Index Percent Change From Baseline After Single Doses of Losartan 100 mg + ISMN 60 mg Versus Single Dose of Placebo
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
This study will qualify a functional model that can measure central blood pressure and vascular compliance effects through noninvasive means.
Investigators
Eligibility 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®
Arms & Interventions
1
losartan 100 mg
Intervention: losartan potassium
Outcomes
Primary Outcomes
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.
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.