NCT03088254已完成3 期
A Multi-center, Randomized, Double-blind, Parellel Phase III Clinical Trial to Evaluate the Efficacy and Safety of Triple Therapy of Telmisartan/Amlodipine/Rosuvastatin in Patients With Dyslipidemia and Hypertension
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 12
- 主要终点
- change of LDL-C
研究概览
简要总结
To evaluate efficacy and safety of co-administrated temisartan/amlodipine and rosuvastatin in subjects with dyslipidemia with hypertension.
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Dyslipidemia with hypertesion
- •msSBP < 180 mmHg
- •msDBP < 110 mmHg
- •LDL-C ≤ 250 mg/dL
- •Triglycerides < 400 mg/dL
排除标准
- •At Visit 3, BP difference SBP ≥20mmHg or DBP ≥10mmHg
- •CK normal range ≥ 2 times
- •Uncontrolled primary hypothyroidism(TSH normal range ≥ 1.5 times)
- •AST or ALT ≥ 2 times
- •Uncontrolled diabetes mellitus (HbA1c≥9%)
- •CLcr < 30 mL/min/1.73m^2
- •K > 5.5 mEq/L
- •Other exclusion applied
研究组 & 干预措施
Group I
Experimental
Treatment of Telmisartan 80 mg, Amodipine 10 mg, Rosuvastatin 20 mg for 8 weeks
干预措施: Group I (Telmisartan 80 mg, Amlodipine 10 mg, Rosuvastatin 20 mg) (Drug)
Group II
Active Comparator
Treatment of Telmisartan 80 mg, Amodipine 10 mg, Rosuvastatin placebo for 8 weeks
干预措施: Group II (Telmisartan 80 mg, Amodipine 10 mg, Rosuvastatin placebo) (Drug)
Group III
Active Comparator
Treatment of Telmisartan 80 mg, Amodipine placebo, Rosuvastatin 20 mg for 8 weeks
干预措施: Group III (Telmisartan 80 mg, Amlodipine placebo, Rosuvastatin 20 mg) (Drug)
结局指标
主要结局
change of LDL-C
时间窗: baseline and 8 weeks
change of msSBP
时间窗: baseline and 8 weeks
次要结局
未报告次要终点
研究者
研究点 (12)
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