A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of MK0736 and MK0916 in Hypertensive Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 249
- 主要终点
- Number of Participants Who Reported a Laboratory Adverse Event
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hypertension systolic blood pressure (SBP) </= 160mm Hg and diastolic blood pressure (DBP): 90-105mm Hg
排除标准
- •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
研究组 & 干预措施
High BMI:MK-0736 2mg→Placebo
Participants administered MK-0736 2mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B)
干预措施: MK0736 (Drug)
High BMI:MK-0736 2mg→Placebo
Participants administered MK-0736 2mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B)
干预措施: Placebo (Drug)
High BMI:MK-0736 7mg→Placebo
Participants administered MK-0736 7mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B)
干预措施: MK0736 (Drug)
High BMI:MK-0736 7mg→Placebo
Participants administered MK-0736 7mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B)
干预措施: Placebo (Drug)
High BMI:MK-0916 6mg→MK-0916 6mg
Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
干预措施: MK0916 (Drug)
High BMI:Placebo→Placebo
Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
干预措施: Placebo (Drug)
Low BMI:MK-0916 6mg→MK-0916 6mg
Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
干预措施: MK0916 (Drug)
Low BMI:Placebo→Placebo
Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants Who Reported a Laboratory Adverse Event
时间窗: 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.
Number of Participants Who Were Discontinued From Study Due to Clinical Adverse Event
时间窗: 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.
Number of Participants Who Were Discontinued From Study Due to Laboratory Adverse Event
时间窗: 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.
Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12 in Participants With Higher Body Mass Indices (BMI)
时间窗: 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.
Number of Participants Who Reported a Clinical Adverse Event
时间窗: 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.
次要结局
- Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 12 in Participants With Higher Body Mass Indices (BMI)(Baseline and Week 12 (end of Phase A))
- Change From Baseline in Body Weight (kg) at Week 12 in Participants With Higher BMI(Baseline and Week 12 (end of Phase A))
- Change From Baseline in Waist Circumference at Week 12 in Participants With Higher BMI(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)(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(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)(Baseline and Week 12 (end of Phase A))