Tolerability of Nebivolol Compared With Metoprolol ER in Patients With Mild to Moderate Hypertension Taking Hydrochlorothiazide (HCTZ)
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 49
- 试验地点
- 24
- 主要终点
- Change From Baseline in the Patient Symptoms Questionnaire (PSQ) Derived Score
研究概览
简要总结
The purpose of this study was to compare the tolerability of nebivolol to metoprolol ER in a general population of patients with mild to moderate hypertension receiving hydrochlorothiazide (HCTZ)
详细描述
This study was an 18-week study to evaluate the tolerability of nebivolol compared to metoprolol ER in outpatients with mild to moderate hypertension taking HCTZ. It is a multi-center, randomized, double blind (DB), active-control, parallel-group study, starting with a 4-week HCTZ run-in phase, followed by a 12-week DB treatment phase. Patients meeting the entry criteria at the end of run-in are randomized to one of two treatment groups, nebivolol or metoprolol ER. Up-titration of dose of study drug will occur if needed during the first 4 weeks of the DB phase, after which there is an 8-week stable-dose period of treatment. A 2-week double-blind withdrawal phase follows, during which tapering off study drug occurs.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Male or female, ambulatory outpatients
- •History of hypertension being treated with two medications, one of which must be HCTZ and the other of which must not be a beta-blocker or clonidine
- •SBP of 135-155 mm Hg and/or DBP of >85 mm Hg at screening (Visit 1)
- •SBP of 140-165 mm Hg and DBP > 90 mmHg at randomization (Visit 3)
排除标准
- •Treatment with a beta-blocker or clonidine within 6 months of screening (Visit 1)
- •Clinically significant respiratory disease (e.g., bronchial asthma, reactive airways disease, chronic obstructive pulmonary disease)
- •Coronary artery disease requiring treatment with a calcium channel blocker or nitrates
- •Clinically significant cardiovascular disease (e.g., myocardial infarction, cerebrovascular event, significant arrhythmia) within 6 months of screening (Visit 1)
- •History of severe mental illness (including Major Depressive Disorder, psychosis, dementia, bipolar disorder) within 6 months of screening (Visit 1)
- •Use of antipsychotic medication (e.g., dopamine receptor antagonists, serotonin dopamine receptor antagonists) or antidepressants
- •Diabetes mellitus, type I or II
- •Participation in a previous investigational study of nebivolol at any time
- •Receipt of treatment with an investigational study drug within 30 days of screening (Visit 1)
- •History of hypersensitivity to nebivolol, metoprolol ER, other beta-blockers, HCTZ, or other sulfonamide-derived drugs
研究组 & 干预措施
Nebivolol
Nebivolol 5 mg, 10 mg or 20 mg
干预措施: Nebivolol (Drug)
Metoprolol ER
Metoprolol ER 50 mg, 100 mg or 200 mg
干预措施: Metoprolol ER (Drug)
结局指标
主要结局
Change From Baseline in the Patient Symptoms Questionnaire (PSQ) Derived Score
时间窗: Measurements occured over a 14 week period, from Visit 2 (Week -2) to Visit 10 (Week 12)
The PSQ contained 44 possible symptoms rated from 0 (no discomfort) to 5 (extreme discomfort).
次要结局
- Peripheral Blood Pressure (BP)(Measurements occured over a 18 week period, from Visit 1 (Week -4) through Visit 11 (Week 14))
- Pulse Rate(Measurements occured over a 18 week period, from Visit 1 (Week -4) through Visit 11 (Week 14))