Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00943852
First received: July 21, 2009
Last updated: March 31, 2014
Last verified: March 2014

July 21, 2009
March 31, 2014
August 2006
December 2006   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: No ]
    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 + ISMN 60 mg Versus Single Dose of Placebo [ Time Frame: Baseline and 10 hours postdose ] [ Designated as safety issue: No ]

    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% after single doses of losartan 100 mg plus ISMN 60 mg versus single dose of losartan 100 mg [ Time Frame: 10 hours postdose ] [ Designated as safety issue: No ]
  • Mean augmentation index% after single doses of losartan 100 mg plus ISMN 60 mg versus single dose of placebo [ Time Frame: 10 hours postdose ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00943852 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
The Effect of Losartan and Losartan Plus Isosorbide Mononitrate on Central Blood Pressure Measurements (0954-317)
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

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

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Diagnostic
Hypertension
  • Drug: losartan potassium
    Single dose losartan 100 mg in one of five treatment periods
    Other Name: COZAAR
  • Drug: Comparator: isosorbide mononitrate (ISMN)
    Single dose ISMN 60 mg in one of five treatment periods
    Other Name: IMDUR
  • Drug: Comparator: losartan + ISMN
    Single dose losartan 100 mg and ISMN 15 mg in one of five treatment periods
  • Drug: Comparator: losartan + ISMN
    Single dose losartan 100 mg and ISMN 60 mg in one of five treatment periods
  • Drug: Comparator: Placebo
    Single dose placebo only in one of five treatment periods
  • Active Comparator: 1
    losartan 100 mg
    Intervention: Drug: losartan potassium
  • Active Comparator: 2
    ISMN 60 mg
    Intervention: Drug: Comparator: isosorbide mononitrate (ISMN)
  • Active Comparator: 3
    losartan 100 mg + ISMN 15 mg
    Intervention: Drug: Comparator: losartan + ISMN
  • Active Comparator: 4
    losartan 100 mg + ISMN 60 mg
    Intervention: Drug: Comparator: losartan + ISMN
  • Placebo Comparator: 5
    Placebo
    Intervention: Drug: Comparator: Placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
13
December 2006
December 2006   (final data collection date for primary outcome measure)

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®
Both
45 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00943852
0954-317, MK0954-317, 2009_610
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP