Blood Pressure and Metabolic Effects of Nebivolol Compared With Hydrochlorothiazide and Placebo in Hypertensive Patients With Impaired Glucose Tolerance or Impaired Fasting Glucose
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 537
- 试验地点
- 88
- 主要终点
- Trough Seated Diastolic Blood Pressure
研究概览
简要总结
This study is being done to see if the blood pressure and metabolic effects of an approved drug nebivolol is comparable to that of another approved drug hydrochlorothiazide (HCTZ) and placebo in hypertensive patients.
详细描述
This study is double blind (neither you nor the physician will know when you are receiving placebo, which is an inactive compound such as a sugar pill, or active study drugs nebivolol or hydrochlorothiazide).
All participants will also receive lisinopril, an angiotensin converting enzyme, or losartan, an angiotensin receptor blocker. All medications are approved and marketed for the treatment of hypertension.This study is being conducted in about 500 patients at approximately 80 research centers in the United States.
The study consists of approximately 9 study visits over a period of 5 months. During these visits, patients will undergo routine health exams and some special laboratory tests such as an oral glucose tolerance test.
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
- Double (Participant, Investigator)
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 18-80 years old at screening.
- •Have a history of hypertension and taking up to 2 medications for high blood pressure.
- •Qualifying laboratory results confirming impaired fasting glucose or impaired glucose tolerance
- •Vision and hearing (hearing aid permissible) sufficient for compliance with questionnaire completion
排除标准
- •Have clinically significant respiratory, liver or cardiovascular disease
- •Presence of coronary artery disease requiring treatment with a beat blocker, calcium channel blocker or nitrates
- •Use of niacin or antidiabetic drugs (oral or injectable) within 6 months before study entry
- •Have a history of hypersensitivity to nebivolol, other beta-blockers, hydrochlorothiazide, or other sulfonamide-derived drugs.
研究组 & 干预措施
Nebivolol
Nebivolol with concomitant losartan or lisinopril
干预措施: Nebivolol with concomitant losartan or lisinopril (Drug)
Hydrochlorothiazide (HCTZ)
HCTZ with concomitant losartan or lisinopril
干预措施: HCTZ with concomitant losartan or lisinopril (Drug)
Placebo
Placebo with concomitant losartan or lisinopril
干预措施: Placebo with concomitant losartan or lisinopril (Drug)
结局指标
主要结局
Trough Seated Diastolic Blood Pressure
时间窗: Change from Baseline Visit 4 (Week 0) To Visit 8 (Week 12)
Change from Baseline in Mean Seated Trough Cuff Diastolic Blood Pressure (DBP) at Week 12, Last Observation Carried Forward (LOCF).
次要结局
- Plasma Glucose Level After an Oral Glucose Tolerance Test(Change from Baseline Visit 3 or 4 (Week -2 or 0) To Visit 8 (Week 12))