NCT00744237已完成4 期
Glycemic Effects of Nebivolol Compared With Metoprolol Extended Release and Compared With Hydrochlorothiazide In Hypertensive Patients With Type 2 Diabetes Mellitus: A Pilot Study
Forest Laboratories50 个研究点 分布在 2 个国家目标入组 231 人开始时间: 2008年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 231
- 试验地点
- 50
- 主要终点
- Change From Baseline in Mean Glycosylated Hemoglobin (HbA1c) at Week 26
研究概览
简要总结
This study will evaluate the effects of nebivolol on glycemic control compared with metoprolol and HCTZ in patients with hypertension and type 2 diabetes mellitus
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
1
Experimental
- Nebivolol 5 mg (overencapsulated 5-mg marketed tablet), oral administration
- Nebivolol 10 mg (overencapsulated 10-mg marketed tablet), oral administration
- Nebivolol 20 mg (overencapsulated 20-mg marketed tablet) oral administration
- Nebivolol 40 mg (two overencapsulated 20-mg tablets) oral administration
- Open-label amlodipine may be given
干预措施: Nebivolol (Drug)
2
Active Comparator
- Metoprolol ER 50 mg (overencapsulated 50-mg tablet) oral administration
- Metoprolol ER 100 mg (two overencapsulated 50-mg tablets) oral administration
- Metoprolol ER 200 mg (overencapsulated 200-mg tablet) oral administration
- Metoprolol ER 400 mg (two overencapsulated 200-mg tablets) oral administration
- Open-label amlodipine may be given
干预措施: Metoprolol ER (Drug)
3
Active Comparator
- HCTZ 12.5 mg (overencapsulated 12.5 capsule), oral administration
- HCTZ 25 mg (two capsules, overencapsulated 12.5-mg capsules), oral administration
- Open-label amlodipine may be given
干预措施: HCTZ (Drug)
结局指标
主要结局
Change From Baseline in Mean Glycosylated Hemoglobin (HbA1c) at Week 26
时间窗: visit 5(week 0) and visit 14(week 26)
Change from baseline in glycosylated hemoglobin (HbA1c) over 26 weeks, Last Observation Carried Forward.
次要结局
- Change From Baseline in Insulin Resistance Based on Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)([visit 5(week 0) and visit 14(week 26)])
研究者
研究点 (50)
Loading locations...
相似试验
已完成
4 期
Comparative Effect of Nebivolol vs. Metoprolol on Insulin Sensitivity and Fibrinolytic Balance in Metabolic SyndromeMetabolic SyndromeNCT00775671Vanderbilt University46
进行中（未招募）
不适用
Comparison the effects of Nebivolol versus Metoprolol succinate on endothelial function and large artery stiffness.A parallel group, randomized, double-blind, active control phase IV clinical trialNEMENDAS - NEMENDASAtherosclerosisEUCTR2005-001578-28-EEBerlin-Chemie AG Menarini Group80
终止
不适用
Comparing the Effects of Two Beta Blockers,Metoprolol and Nebivolol,on Ambulatory Blood Pressure and Basal Metabolic RateHypertensionNCT00849810University of Mississippi Medical Center1
已完成
4 期
Nebivolol Versus Metoprolol: Sodium SensitivityHypertensionNCT00992056University of Miami24
已完成
3 期
Comparison of 2 Beta Blocker Drugs on Peripheral Arterial Disease in Patients With High Blood PressurePeripheral Artery DiseaseHypertensionNCT01499134Thomas Jefferson University17