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

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

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

Conditions
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Hypertension

Intervention / Treatment
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* Drug: MK0736
* Drug: MK0916
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High BMI:MK-0736 2mg→Placebo<br>Participants administered MK-0736 2mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B) | Drug: MK0736<br> <br> Drug: Placebo<br> <br> |
| Experimental: High BMI:MK-0736 7mg→Placebo<br>Participants administered MK-0736 7mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B) | Drug: MK0736<br> <br> Drug: Placebo<br> <br> |
| Experimental: High BMI:MK-0916 6mg→MK-0916 6mg<br>Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks) | Drug: MK0916<br> <br> |
| Placebo Comparator: High BMI:Placebo→Placebo<br>Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks) | Drug: Placebo<br> <br> |
| Experimental: Low BMI:MK-0916 6mg→MK-0916 6mg<br>Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks) | Drug: MK0916<br> <br> |
| Placebo Comparator: Low BMI:Placebo→Placebo<br>Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks) | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12 in Participants With Higher Body Mass Indices (BMI) | 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. | Baseline and Week 12 (end of Phase A) | 
| Number of Participants Who Reported a Clinical Adverse Event | 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. | 24 weeks | 
| Number of Participants Who Reported a Laboratory Adverse Event | 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. | 24 weeks | 
| Number of Participants Who Were Discontinued From Study Due to Clinical Adverse Event | 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. | 24 weeks | 
| Number of Participants Who Were Discontinued From Study Due to Laboratory Adverse Event | 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. | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 12 in Participants With Higher Body Mass Indices (BMI) | 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. | Baseline and Week 12 (end of Phase A) | 
| Change From Baseline in Body Weight (kg) at Week 12 in Participants With Higher BMI | 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. | Baseline and Week 12 (end of Phase A) | 
| Change From Baseline in Waist Circumference at Week 12 in Participants With Higher BMI | Waist circumference measured in cm at baseline and after 12 weeks of study drug administration | Baseline and Week 12 (end of Phase A) | 
| Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 in Participants With Higher Body Mass Indices (BMI) | LDL-C was calculated by the method of Friedewald equation at baseline and after 12 weeks of study drug administration. | Baseline and Week 12 (end of Phase A) | 
| Change From Baseline for High Density Lipoprotein Cholesterol (HDL-C) at Week 12 in Participants With Higher BMI | HDL-C measured at baseline and after 12 weeks of study drug administration. | Baseline and Week 12 (end of Phase A) | 
| Percent Change From Baseline in Triglycerides (TG) at Week 12 in Participants With Higher Body Mass Indices (BMI) | TG measured at baseline and after 12 weeks of study drug administration | Baseline and Week 12 (end of Phase A) |