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

NCT ID: NCT00943852

Last Updated: 2022-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-08-31
• Study Completion Date: 2006-12-31

Brief Summary

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

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Study Groups

1

losartan 100 mg

Group Type: ACTIVE_COMPARATOR

losartan potassium

Intervention Type: DRUG

Single dose losartan 100 mg in one of five treatment periods

2

ISMN 60 mg

Group Type: ACTIVE_COMPARATOR

Comparator: isosorbide mononitrate (ISMN)

Intervention Type: DRUG

Single dose ISMN 60 mg in one of five treatment periods

3

losartan 100 mg + ISMN 15 mg

Group Type: ACTIVE_COMPARATOR

Comparator: losartan + ISMN

Intervention Type: DRUG

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

4

losartan 100 mg + ISMN 60 mg

Group Type: ACTIVE_COMPARATOR

Comparator: losartan + ISMN

Intervention Type: DRUG

Single dose losartan 100 mg and ISMN 60 mg in one of five treatment periods

5

Placebo

Group Type: PLACEBO_COMPARATOR

Comparator: Placebo

Intervention Type: DRUG

Single dose placebo only in one of five treatment periods

Interventions

losartan potassium

Single dose losartan 100 mg in one of five treatment periods

Intervention Type: DRUG

Comparator: isosorbide mononitrate (ISMN)

Single dose ISMN 60 mg in one of five treatment periods

Intervention Type: DRUG

Comparator: losartan + ISMN

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

Intervention Type: DRUG

Comparator: losartan + ISMN

Single dose losartan 100 mg and ISMN 60 mg in one of five treatment periods

Intervention Type: DRUG

Comparator: Placebo

Single dose placebo only in one of five treatment periods

Intervention Type: DRUG

Other Intervention Names

COZAAR; IMDUR

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®

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

Kaufman R, Nunes I, Bolognese JA, Miller DL, Salotti D, McCarthy JM, Smith WB, Herman GA, Feig PU. Single-dose effects of isosorbide mononitrate alone or in combination with losartan on central blood pressure. J Am Soc Hypertens. 2010 Nov-Dec;4(6):311-8. doi: 10.1016/j.jash.2010.10.004.

Reference Type: RESULT

PMID: 21130977 (View on PubMed)

Other Identifiers

MK0954-317

Identifier Type: -

Identifier Source: secondary_id

2009_610

Identifier Type: -

Identifier Source: secondary_id

0954-317

Identifier Type: -

Identifier Source: org_study_id