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

Organon

Status and phase: Completed; Phase 1

Conditions: Hypertension

Treatments: Drug: losartan potassium; Drug: Comparator: isosorbide mononitrate (ISMN); Drug: Comparator: Placebo; Drug: Comparator: losartan + ISMN

Study type: Interventional

Funder types: Industry

Identifiers

NCT00943852

MK0954-317

0954-317

2009_610

Details and patient eligibility

About

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

Enrollment: 13 patients

Sex: All

Ages: 45 to 70 years old

Volunteers: No Healthy Volunteers

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®

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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13 participants in 5 patient groups, including a placebo group

1

Active Comparator group

Description:

losartan 100 mg

Treatment:

Drug: losartan potassium

2

Active Comparator group

Description:

ISMN 60 mg

Treatment:

Drug: Comparator: isosorbide mononitrate (ISMN)

3

Active Comparator group

Description:

losartan 100 mg + ISMN 15 mg

Treatment:

Drug: Comparator: losartan + ISMN

Drug: Comparator: losartan + ISMN

4

Active Comparator group

Description:

losartan 100 mg + ISMN 60 mg

Treatment:

Drug: Comparator: losartan + ISMN

Drug: Comparator: losartan + ISMN

5

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Comparator: Placebo