A Worldwide, Multicenter, Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy & Tolerability of MK0736 When Added to Ongoing Therapy With Angiotensin-Converting Enzyme Inhibitor (ACEI) or Angiotensin Receptor Blocker (ARB) in Patients With T2DM and Hypertension
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 620
- 主要终点
- Change From Baseline in Sitting Diastolic Blood Pressure (SiDBP) at Week 12
研究概览
简要总结
The study will assess the efficacy and tolerability of MK0736 in patients with Type 2 Diabetes Mellitus and Hypertension who are on ongoing therapy with Angiotensin-Converting Enzyme or Angiotensin Receptor Blocker. After a 3 to 5 week pre-randomization phase, patients will be randomized to either MK0736 (3 doses), placebo, or hydrochlorothiazide (HCTZ). The study will also include a 3 week, posttreatment follow-up period.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be 18 to 75 years of age
- •Type 2 Diabetes Mellitus (Glycohemoglobin [A1CHbA1c]: 7 to 10%)
- •Hypertension: Diastolic blood pressure (DBP; 85 to 99 mm Hg) and systolic blood pressure (SBP; 120 to 159 mm Hg)
- •LDL-C < 140 mg/dL
- •On stable treatment with an Angiotensin-Converting Enzyme Inhibitor (ACEI) or Angiotensin Receptor Blocker (ARB)
排除标准
- •History of Type I Diabetes mellitus or ketoacidosis
- •Patients taking 3 or more blood pressure lowering medications
- •Have severe chronic heart failure
- •History of certain diseases or conditions such as cardiac arrhythmias, heart attack, stroke, unstable angina, or decompensated vascular disease
- •History of cancer within the last 5 years
- •Human immunodeficiency virus (HIV) Positive
- •Have received treatment with any investigational drugs within the past 30 days
- •History of alcohol or drug abuse within the past 3 years
- •Body Mass Index ( BMI) >= 41 kg/m2
研究组 & 干预措施
MK-0736 0.5 mg
One MK-0736 0.5 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B).
干预措施: MK-0736 (Drug)
MK-0736 2.0 mg
One MK-0736 2.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for 52 weeks (Phase B).
干预措施: MK-0736 (Drug)
MK-0736 8.0 mg
One MK-0736 8.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will continue to receive MK-0736 8.0 mg, once daily for 52 weeks (Phase B).
干预措施: MK-0736 (Drug)
HCTZ 12.5 mg → MK-0736 8.0 mg
one 12.5 mg hydrochlorothiazide (HCTZ) tablet daily, orally, for 12 weeks. Participant then switched to MK-0736 8.0 mg for 12 weeks (Phase A). Participant will continue to receive MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B).
干预措施: MK-0736 (Drug)
结局指标
主要结局
Change From Baseline in Sitting Diastolic Blood Pressure (SiDBP) at Week 12
时间窗: Baseline and Week 12
Participant remained in the sitting position for at least 5 minutes before any blood pressure readings were recorded. Systolic and diastolic blood pressures were determined by taking 6 replicate measurements obtained 1 to 2 minutes apart. First reading was discarded and the average of the last 5 measurement was recorded.
Change From Baseline in Sitting Systolic Blood Pressure (SiSBP) at Week 12
时间窗: Baseline and Week 12
Participant remained in the sitting position for at least 5 minutes before any blood pressure readings were recorded. Systolic and diastolic blood pressures were determined by taking 6 replicate measurements obtained 1 to 2 minutes apart. First reading was discarded and the average the last 5 measurement was recorded.
次要结局
- Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12(Baseline and Week 12)
- Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24(Baseline and Week 24)
- Change From Baseline in Body Weight at Week 24(Baseline and Week 24)