Evaluation of the Efficacy, Safety, and Pharmacokinetics/Pharmacodynamics of BAY A1040 CR Tablet on High Dose Administration in Patients With Essential Hypertension.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 35
- 主要终点
- Change of Sitting Blood Pressure
研究概览
简要总结
This is a multi-center, randomized, double-blind, 6 x 3 cross-over study. All patients who meet the entry criteria will be required to stop taking any other anti-hypertensive agents than Adalat CR (controlled release), if taken, before starting 4 weeks (±7days) open-label Adalat CR 40 mg once daily (OD) treatment phase (baseline treatment period). Of them, those who are confirmed with their eligibility as subjects for the present study at the end of the baseline treatment period will be randomly allocated to one of the 6 treatment sequences on the basis of a computer-generated randomization list. Subsequently, BAY A1040 CR tablet 40 mg OD, 40 mg twice daily (BID) or 80 mg OD will be administered to a total of 6 weeks, 2 weeks per each treatment period (Period 1-3) under double-blind conditions using BAY A1040 CR tablet 40 mg and its placebo as follows (Double-blind treatment period).
详细描述
Issues on safety are addressed in the Adverse Event section.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female
- •20 years or older and less than 75 years
- •Outpatient
- •Untreated or treated patients with antihypertensive agents whose blood pressure (BP) in sitting position at entry (Visit 1) is as follows.
- •Untreated patients: systolic blood pressure (SBP) >= 160mmHg or diastolic blood pressure (DBP) >= 100mmHg
- •Treated patients: SBP >= 140mmHg or DBP >= 90mmHg (at trough)
排除标准
- •Patients whose BP during baseline treatment period is: SBP>=200mmHg or DBP>=120mmHg.
- •Patients with secondary hypertension or hypertensive emergency.
- •Patients with cardiovascular or cerebrovascular ischemic event (stroke, transient ischemic attack (TIA), myocardial infarction or unstable angina), or with history of these within 6 months prior to the study.
- •Patients with intracranial or subarachnoid hemorrhage, or with history of these within 6 months prior to the study.
- •Patients with server hematopoietic dysfunction (acute/chronic leukemia, myeloma, malignant lymphoma, myelodysplastic syndrome, aplastic anemia), or with history of these.
研究组 & 干预措施
Nifedipine (Adalat CR, BAYA1040) 40 mg OD
Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) once daily (OD) in the morning
干预措施: Nifedipine (Adalat CR, BAYA1040) 40mg OD (Drug)
Nifedipine (Adalat CR, BAYA1040) 40 mg BID
Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) twice daily (BID). 40 mg in the morning and 40 mg in the evening
干预措施: Nifedipine (Adalat CR, BAYA1040) 40mg BID (Drug)
Nifedipine (Adalat CR, BAYA1040) 80 mg OD
Nifedipine (Adalat CR, BAYA1040) 80 milligram (mg) once daily (OD) in the morning
干预措施: Nifedipine (Adalat CR, BAYA1040) 80mg OD (Drug)
结局指标
主要结局
Change of Sitting Blood Pressure
时间窗: Baseline and after 2 weeks treatment
Changes of sitting SBP and DBP (trough values) from baseline (ie \[trough BP at the end of each period during the double-blind treatment period\] minus \[trough BP at the end of the baseline treatment period\])
次要结局
- Target Blood Pressure Achievement in All Subjects(After 2 weeks treatment)
- Target Blood Pressure Achievement in Subjects With Diabetes Mellitus or Chronic Renal Disorder(After 2 weeks treatment)
- Differences of Systolic Blood Pressure Profile(Baseline and after 2 weeks treatment)
- Differences of Diastolic Blood Pressure Profile(Baseline and after 2 weeks treatment)
- Target Blood Pressure Achievement in Non-elderly (<65)(After 2 weeks treatment)
- Target Blood Pressure Achievement in Elderly (≥65)(After 2 weeks treatment)