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Completed

NCT Number: NCT00274716

Safety and Efficacy of MK0736 & MK0916 in Patients With Hypertension (High Blood Pressure)(0736-003)(COMPLETED)

The objective of this study is to evaluate the safety and efficacy of two investigational drugs (MK-0736 and MK-0916) in lowering blood pressure and body weight in patients with hypertension (high blood pressure).

This is an early phase trial and some specific protocol information is proprietary and not publicly available at this time. (Full information is available to trial participants).

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

Participants enrolled in the study will be separated into 2 strata based on baseline body mass index (BMI) assessments prior to being randomly assigned to study treatment. Study will include a 24-week treatment period comprised of 2 phases, A and B, each of which will 12 weeks in duration.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Hypertension systolic blood pressure (SBP) </= 160mm Hg and diastolic blood pressure (DBP): 90-105mm Hg

Exclusion criteria

  • Pre-menopausal women
  • patients currently taking more than two (2) blood pressure lowering medications
  • Body Mas Index (BMI)>40 kg/m2 (morbidly obese patients)
  • History of Alcohol abuse (<3 Years)
  • History of diabetes,chronic kidney disease, Active liver disease, recent heart attack or stroke

Treatment and study plan

MK0736

Drug

MK0916

Drug

Placebo

Drug

Primary outcomes

  1. Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12 in Participants With Higher Body Mass Indices (BMI)

    Time frame: Baseline and Week 12 (end of Phase A)

    Sitting diastolic blood pressure measured in triplicate at baseline and after 12 weeks of study drug administration. Mean value of the 3 measurements at the 2 timepoints was recorded.

  2. Number of Participants Who Reported a Clinical Adverse Event

    Time frame: 24 weeks

    An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR'S product, is also an AE. A clinical AE was an AE reported as a result of a clinical examination.

  3. Number of Participants Who Reported a Laboratory Adverse Event

    Time frame: 24 weeks

    An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR'S product, is also an AE. A laboratory AE was an AE reported as a result of a laboratory assessment or test.

  4. Number of Participants Who Were Discontinued From Study Due to Clinical Adverse Event

    Time frame: 24 weeks

    An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR'S product, is also an AE. A clinical AE was an AE reported as a result of a clinical examination.

  5. Number of Participants Who Were Discontinued From Study Due to Laboratory Adverse Event

    Time frame: 24 weeks

    An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR'S product, is also an AE. A laboratory AE was an AE reported as a result of a laboratory assessment or test.

Secondary outcomes

  1. Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 12 in Participants With Higher Body Mass Indices (BMI)

    Time frame: Baseline and Week 12 (end of Phase A)

    Sitting systolic blood pressure measured in triplicate at baseline and after 12 weeks of study drug administration. Mean trough value of the 3 measurements at the 2 timepoints was recorded.

  2. Change From Baseline in Body Weight (kg) at Week 12 in Participants With Higher BMI

    Time frame: Baseline and Week 12 (end of Phase A)

    Weight was measured in duplicate (2 measurements) at baseline and after 12 weeks of study drug administration. The mean of the 2 values at each assessment was used in analysis.

  3. Change From Baseline in Waist Circumference at Week 12 in Participants With Higher BMI

    Time frame: Baseline and Week 12 (end of Phase A)

    Waist circumference measured in cm at baseline and after 12 weeks of study drug administration

  4. Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 in Participants With Higher Body Mass Indices (BMI)

    Time frame: Baseline and Week 12 (end of Phase A)

    LDL-C was calculated by the method of Friedewald equation at baseline and after 12 weeks of study drug administration.

  5. Change From Baseline for High Density Lipoprotein Cholesterol (HDL-C) at Week 12 in Participants With Higher BMI

    Time frame: Baseline and Week 12 (end of Phase A)

    HDL-C measured at baseline and after 12 weeks of study drug administration.

  6. Percent Change From Baseline in Triglycerides (TG) at Week 12 in Participants With Higher Body Mass Indices (BMI)

    Time frame: Baseline and Week 12 (end of Phase A)

    TG measured at baseline and after 12 weeks of study drug administration

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of MK0736 and MK0916 in Hypertensive Patients

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Jan 11, 2006
Registry last updated
Jul 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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