NCT00679653已完成3 期
Blood Pressure and Weight Trajectory on a Dual Antihypertensive Combination Plus Sibutramine Versus Placebo in Obese Hypertensives
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 171
- 主要终点
- Systolic Blood Pressure
研究概览
简要总结
To study the effect of sibutramine treatment on weight reduction and blood pressure improvement in three groups with antihypertensive therapy whose blood pressure was not adequately controlled with antihypertensive combination treatment.
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
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Treated essential hypertension.
- •Obesity: BMI 27-35 kg/m2
排除标准
- •Secondary hypertension.
- •Stage 3 hypertension.
- •Secondary obesity; BMI > 35kg/m
- •CAD; MI within past 6 months; NYHA stage 3 or 4 heart failure; tachyarrhythmia/atrial fibrillation; myocarditis.
- •Kidney failure.
- •Liver failure.
- •Hyperthyroidism.
- •Unstable DM.
- •Carcinoma.
- •Severe chronic infectious disease.
- •Alcohol or drug abuse.
- •Pregnancy.
- •Epilepsy.
- •Psychosis or treatment with antidepressants or major tranquilizers
研究组 & 干预措施
3
Active Comparator
felodipine/ramipril
干预措施: felodipine/ramipril (Drug)
1
Active Comparator
verapamil/trandolapril
干预措施: sibutramine (Drug)
1
Active Comparator
verapamil/trandolapril
干预措施: verapamil/trandolapril (Drug)
2
Active Comparator
metoprolol/HCT
干预措施: sibutramine (Drug)
2
Active Comparator
metoprolol/HCT
干预措施: metoprolol/HCT (Drug)
3
Active Comparator
felodipine/ramipril
干预措施: sibutramine (Drug)
结局指标
主要结局
Systolic Blood Pressure
时间窗: Duration of Study
Diastolic Blood Pressure
时间窗: Duration of Study
次要结局
未报告次要终点
研究者
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终止
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