A Study of a Hypertensive Population Under Treatment With Micardis® and Micardis Plus® Under Real Clinical Conditions With the Goal to Control the Early Morning BP Rise (SURGE II)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5,248
- 主要终点
- Change of degree of Blood Pressure (BP) control in the early morning hours
研究概览
简要总结
The primary objective was to evaluate, through the use of Home blood pressure monitoring (HBPM), the degree of BP control in the early morning hours after 8 weeks of treatment in patients with essential hypertension under treatment with Micardis®, Telmisartan or Micardis Plus®, Telmisartan hydrochlorothiazide.
The co-primary endpoints were the degree of BP control, and change from baseline until study end in mean systolic blood pressure (mSBP) and mean diastolic blood pressure (mDBP) HBPM in the early morning hours after 8 weeks of treatment with Micardis®, Telmisartan or Micardis Plus®, Telmisartan hydrochlorothiazide.
Secondary endpoints were office BP control rates, office BP response rates, and reduction in mSBP and mDBP Office blood pressure measurement (OBPM) from baseline to final visit, discontinuations and tolerability
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients male or female between 18 and 80 years of age
- •Patients with mild to moderate essential hypertension
- •Patients diagnosed with hypertension that are not currently taking antihypertensive medication or previously diagnosed hypertensive patients who are uncontrolled with their current treatment
排除标准
- •Pre-menopausal women who have no birth control, who are pregnant or nursing
- •Patients with advanced hepatic impairment or advanced renal impairment
- •Patients with New York Heart Association (NYHA) functional class III or IV congestive heart failure (CHF), unstable angina, acute myocardial infarction, heart surgery or stroke within the previous six months
- •Patients with any type of relevant arrhythmia according to the assessment of the investigator
- •Patients with any valvular disease with hemodynamic repercussion
- •Patients receiving chronic administration of oral anticoagulants or digoxin
- •Patients with known hypersensitivity to any component in the formulation of Micardis®, Telmisartan or Micardis Plus®, Telmisartan hydrochlorothiazide
- •Patients with previous history of angioedema associated with angiotensin converting enzyme (ACE) inhibitors
- •Patients with severe, uncontrolled hypertension or any form of secondary hypertension
- •Patients with any other clinical conditions which, in the opinion of the investigator, would not allow for the safe completion of the protocol
研究组 & 干预措施
Hypertensive patients
干预措施: Telmisartan (Drug)
Hypertensive patients
干预措施: Telmisartan hydrochlorothiazide (Drug)
结局指标
主要结局
Change of degree of Blood Pressure (BP) control in the early morning hours
时间窗: 8 weeks of treatment
Change from baseline in mSBP and mDBP by HBPM in the early morning
时间窗: Baseline, after 8 weeks of treatment
BP control during the morning time-periods (6:00 to 11:59), BP \< 135/85 mmHg (HBPM: mean of morning measurements)
次要结局
- Change from baseline in office BP control rates(Baseline, after 8 weeks)
- Change from baseline in office BP response rates(Baseline, after 8 weeks)
- Reduction in mSBP and mDBP by OBPM(Baseline, after 8 weeks)
- Number of patients with adverse events(up to 8 weeks)
- Global Assessment of tolerability by investigator on a 6-point scale(after 8 weeks)
- Global assessment efficacy by investigator on 6-point scale(after 8 weeks)