Clinical Effect and Cost Effectiveness of Ca Antagonist in Combination With AII Receptor Antagonist in Patient With Essential Hypertension (PMS Study)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 514
- 主要终点
- Mean treatment cost* for 16-week of double-blind treatment period
研究概览
简要总结
The primary objective of this study is to investigate incremental cost effectiveness of Nifedipine CR and Amlodipine in combination therapy with Valsartan for the treatment of essential hypertensive patients.
To investigate incremental cost effectiveness, primary variables are mean treatment cost and achievement rate to target blood pressure level at the end of double-blind treatment 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Untreated patients or patients with previous treatment by antihypertensive agents whose blood pressure at sitting position at the time of the entry (Visit 1) is:
- •SBP>/=160mmHg or DBP>/=100mmHg for untreated patients (SBP Systolic blood pressure, DBP Diastolic blood pressure)
- •SBP>/=150mmHg or DBP>/=95mmHg for patients with previous treatment by antihypertensive agents
排除标准
- •Patients whose blood pressure on either day of Visit 1 or 2 is: SBP > 200mmHg or DBP > 120mmHg.
- •Patients with secondary hypertension or hypertensive emergency such as malignant hypertension.
- •Patients with a history of cardiovascular or cerebrovascular ischemic event (stroke, transient ischemic attack, myocardial infarction or unstable angina) within six months prior to the study.
- •Patients with a history of intracranial or subarachnoid hemorrhage within six months prior to the study.
- •Patients with uncontrolled diabetes (HbA1c >/=8%)
- •Patients with bradycardia or tachycardia (<50 bpm, >/=100 bpm), arrhythmia such as atrioventricular block (second and third degree), sinoatrial block or atrial fibrillation.
研究组 & 干预措施
Arm 1
Adalat CR 20-40mg od + Diovan 40-80mg od
干预措施: Nifedipine (Adalat, BAYA1040) (Drug)
Arm 1
Adalat CR 20-40mg od + Diovan 40-80mg od
干预措施: Diovan (Drug)
Arm 2
Norvasc 2.5-5mg od + Diovan 40-80mg od
干预措施: Amlodipine (Norvasc) (Drug)
Arm 2
Norvasc 2.5-5mg od + Diovan 40-80mg od
干预措施: Diovan (Drug)
结局指标
主要结局
Mean treatment cost* for 16-week of double-blind treatment period
时间窗: 16 weeks
\* Including treatment cost for the drug related AEs. The sponsor will calculate the cost based on the tariff of health insurance scores.
Proportion of participants** achieving target blood pressure at the end of double-blind treatment period
时间窗: at week 16
\*\*For subjects aged under 60 years: SBP\<130mmHg and DBP\<85mmHg, for subjects aged 60 years or over: SBP\<140mmHg and DBP\<90mmHg (SBP Systolic blood pressure, DBP Diastolic blood pressure)
次要结局
- Treatment cost per subject to achieve the target blood pressure (Total costs for the double-blind treatment period / Number of patients who achieve the target blood pressure at the end of double-blind treatment period)(16 weeks)
- The change in blood pressure (SBP and DBP) from the baseline (end of pretreatment period) .(baseline to week 16)
- Proportion of participants for each age group to target blood pressure level(at week 16)
- Incidence of treatment-emergent drug-related adverse events(16 weeks)
- Safety variables will be summarized using descriptive statistics based on adverse events collections(16 weeks)