Phase 1 N=13 Randomized Double-blind Diagnostic

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

Hypertension

Bottom Line

View on ClinicalTrials.gov: NCT00943852 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2010

Primary outcome: Primary: 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 — -24.9; -1.8 Percent Change — p=<0.001

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: losartan potassium (Drug); Comparator: isosorbide mononitrate (ISMN) (Drug); Comparator: losartan + ISMN (Drug); Comparator: Placebo (Drug)
Age: Adult, Older Adult · 45+ yrs
Sex: All
Sponsor: Organon and Co
Primary completion: Dec 2006

Outcome Measures

Outcome	Result	p-value
PRIMARY 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	-24.9; -1.8	<0.001 sig
PRIMARY Mean Augmentation Index Percent Change From Baseline After Single Doses of Losartan 100 mg + ISMN 60 mg Versus Single Dose of Placebo	-24.9; -1.3	<0.001 sig

Summary

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

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®

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00943852). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.