NCT00654745已完成4 期
A Prospective, Open-label, Ambulatory Blood Pressure Monitoring (ABPM) Dose Titration Study to Evaluate the Safety and Efficacy of an Olmesartan Medoxomil and Amlodipine Based Treatment Regimen in Hypertensive, Type 2 Diabetic Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 207
- 主要终点
- Change From Week 0 (Baseline) in Mean 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure (SBP) After 12 Weeks of Active Treatment
研究概览
简要总结
To determine if olmesartan plus amlodipine combination therapy alone and with hydrochlorothiazide will be safe and effective to reduce high blood pressure in hypertensive, type 2 diabetic subjects.
详细描述
This is a single group study in which participants were titrated to the next of 6 regimens if blood pressure (BP) goals were not met.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females aged 18 to 80 years.
- •Diagnosis of type 2 diabetes mellitus and on a stable regimen of any oral antidiabetic agent(s) for at least 3 months, with or without adjunctive use of Byetta (exenatide);
- •Note: Subjects diagnosed with type 2 diabetes mellitus who were not on oral antidiabetic agents may have been enrolled if they had a documented history of type 2 diabetes by American Diabetes Association criteria, including the specific plasma glucose results listed below:
- •Fasting plasma glucose >=126 mg/dL (7.0 mmol/L); or
- •Symptoms of hyperglycemia and a casual (any time of day without regard to time since last meal) plasma glucose >=200 mg/dL (11.1 mmol/L). The classic symptoms of hyperglycemia were considered to include polyuria, polydipsia, and unexplained weight loss; or
- •Two-hour plasma glucose >=200 mg/dL (11.1 mmol/L) during an oral glucose tolerance test;
- •Newly diagnosed hypertension or uncontrolled hypertension (defined as SBP >130 mmHg and/or DBP >80 mmHg) on current antihypertensive monotherapy or combination therapy.
- •Subjects must fulfill mean seated office blood pressure parameters at two consecutive, qualifying visits during the placebo run-in phase, and, subsequently, daytime ambulatory blood pressure monitoring (ABPM) criteria.
- •Females should not be pregnant or lactating and, if applicable, using adequate contraception.
排除标准
- •Subjects with uncontrolled hypertension taking multiple antihypertensive therapies (at the discretion of the investigator).
- •Type 2 diabetes mellitus with a glycosylated hemoglobin A1c (HbA1c) >=9.0% at screening;
- •Subjects with type 1 or type 2 diabetes mellitus requiring insulin.
- •Subjects with any serious disorder which may limit the ability to evaluate the safety and efficacy of study medication, or subjects with secondary hypertension.
研究组 & 干预措施
aml + olm + hctz
Experimental
amlodipine; and olmesartan medoxomil, if required; and hydrochlorothiazide, if required.
干预措施: Amlodipine (Drug)
aml + olm + hctz
Experimental
amlodipine; and olmesartan medoxomil, if required; and hydrochlorothiazide, if required.
干预措施: amlodipine / olmesartan medoxomil combination (Drug)
aml + olm + hctz
Experimental
amlodipine; and olmesartan medoxomil, if required; and hydrochlorothiazide, if required.
干预措施: Hydrochlorothiazide (Drug)
结局指标
主要结局
Change From Week 0 (Baseline) in Mean 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure (SBP) After 12 Weeks of Active Treatment
时间窗: week 0 - week 12
Change from week 0 (baseline) in mean 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure (SBP) after 12 weeks of active treatment. change = week 12 - week 0.
次要结局
- Change From Week 0 (Baseline) in Mean ABPM Diastolic Blood Pressure (DBP) After 12 Weeks of Active Treatment(week 0 - week 12 (24-hour, Daytime, Nighttime, Last 6 hour, Last 4 hour, Last 2 hour))
- Change From Week 0 (Baseline) in Mean ABPM SBP After 12 Weeks of Active Treatment(week 0 - week 12 (24-hour, Daytime, Nighttime, Last 6 hour, Last 4 hour, Last 2 hour))
- Change in Mean Seated Systolic Blood Pressure (SeSBP) From Week 0 (Baseline) After 3, 6, 9, 12, 15, and 18 Weeks(week 0 - weeks 3, 6, 9, 12, 15, 18)
- Change in Mean Seated Diastolic Blood Pressure (SeDBP) From Week 0 (Baseline) After 3, 6, 9, 12, 15, and 18 Weeks(week 0 - weeks 3, 6, 9, 12, 15, 18)
- Number of Participants Achieving Mean 24-hour Ambulatory Blood Pressure Thresholds at Week 12(week 0 - week 12)
- Number of Participants Achieving Mean Daytime Ambulatory Blood Pressure Thresholds at Week 12(week 0 - week 12)
- Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 3(week 0 - week 3)
- Number of Participants Achieving Mean Nighttime Ambulatory Blood Pressure Thresholds at Week 12(week 0 - week 12)
- Number of Participants Achieving Mean Last 6 Hour Ambulatory Blood Pressure Thresholds at Week 12(week 0 - week 12)
- Number of Participants Achieving Mean Last 4 Hour Ambulatory Blood Pressure Thresholds at Week 12(week 0 - week 12)
- Number of Participants Achieving Mean Last 2 Hour Ambulatory Blood Pressure Thresholds at Week 12(week 0 - week 12)
- Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 6(week 0 - week 6)
- Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 9(week 0 - week 9)
- Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 12(week 0 - week 12)
- Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 15(week 0 - week 15)
- Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 18(week 0 - week 18)
- Number of Participants Achieving Mean 24 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12(week 0 - week 12)
- Number of Participants Achieving Mean Daytime Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12(week 0 - week 12)
- Number of Participants Achieving Mean Nighttime Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12(week 0 - week 12)
- Number of Participants Achieving Mean Last 6 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12(week 0 - week 12)
- Number of Participants Achieving Mean Last 4 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions(week 0 - week 12)
- Number of Participants Achieving Mean Last 2 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12(week 0 - week 12)
- Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 3(week 0 - week 3)
- Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 6(week 0 - week 6)
- Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 9(week 0 - week 9)
- Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 12(week 0 - week 12)
- Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 15(week 0 - week 15)
- Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 18(week 0 - week 18)
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