NCT00987662撤回4 期
Double Blind Study of Irbesartan vs. Amlodipine in Obese Hypertensive Subjects- The OBI Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Reduction of 24h BP and arterial stiffness in obese hypertensives
研究概览
简要总结
Objective:
- To study the effectiveness of irbesartan 300mg and amlodipine 10 mg in 24h ambulatory blood pressure values in obese subjects
- To study the drug specific effect in arterial stiffness
- To study possible drug mechanisms in obesity (reduction of central adiposity and changing the ratio of leptin to adiponectin)
详细描述
Study Objectives
- Primary:
- Reduction of 24h BP in obese hypertensives
- Reduction in arterial stiffness
- Secondary
- Drug specific effect on new onset of diabetes
- Drug specific effect on reduction in central fat deposition and the leptin to adiponectin ratio
Study design
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 60 years.
- •All patients are going to give their informed consent to participate in the study.
- •Stage I hypertension.
排除标准
- •Known oversensitiveness,
- •Chronic renal disease (GFR < 50 ml/min) or ESRD,
- •Heart or respiratory failure, OR
- •Recent MI, shock, liver deficiency (ALT or AST > 3 times normal and pregnancy or lactation.
研究组 & 干预措施
Irbesartan
Active Comparator
Treatment with irbesartan 300mg for 4 weeks. IF ABP>135/85 mmHg add HCZ 12.5 mg.
干预措施: Irbesartan (Drug)
Amplodipine
Active Comparator
Treatment with amlodipine 10 mg for 4 weeks. If BP>135/85 mmHg add hydrochlorothiazide 12.5 mg
干预措施: Amlodipine (Drug)
结局指标
主要结局
Reduction of 24h BP and arterial stiffness in obese hypertensives
时间窗: 12
次要结局
- New onset of diabetes(12)
- Drug specific effect on reduction in central fat deposition and the leptin to adiponectin ratio(12)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Clinical Efficacy and Safety Evaluation of Irbesartan and Amlodipine Combined Therapy in Essential Hypertension PatientsEssential HypertensionNCT05476354Handok Inc.271
已完成
3 期
Clinical Efficacy and Safety Evaluation of Irbesartan High and Amlodipine Combined Therapy in Essential Hypertension PatientsEssential HypertensionNCT05475665Handok Inc.157
已完成
1 期
Pharmacokinetics of Irbesartan/Amlodipine High FDC and Co-administration of Irbesartan and Amlodipine High in Healthy VolunteersHealthy VolunteersNCT05688098Handok Inc.44
已完成
1 期
Pharmacokinetics of Irbesartan High/Amlodipine FDC and Co-administration of Irbesartan High and Amlodipine in Healthy VolunteersHealthy VolunteersNCT05688085Handok Inc.44
已完成
1 期
Pharmacokinetics of Irbesartan/Amlodipine FDC and Co-administration of Irbesartan and Amlodipine in Healthy VolunteersHealthy VolunteersNCT05663073Handok Inc.46