NCT01541943已完成3 期
A Phase 3, Randomized, Double- Blind, Multi-center, Double Dummy, Clinical Trial Comparing HL-040XC With Single Component Therapies(Atorvastatin, Losartan) to Assess the Efficacy and Safety of HL-040XC in Patients With Essential Hypertension and Hyperlipidemia
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
- 356
- 试验地点
- 1
- 主要终点
- Change from baseline to 8 week in SiDBP (Sitting Diastolic Blood Pressure)
研究概览
简要总结
The purpose of this study is to evaluate efficacy and safety of HL-040XC in patients with essential hypertension and hyperlipidemia
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
- •Aged between 18 and 80 years
- •History of essential hypertension and hyperlipidemia
- •Able to sign informed consent
排除标准
- •At screening, SBP ≥ 180mmHg or DBP ≥ 110mmHg or LDL-C > 250mg/dL or TG ≥ 400mg/dL
- •Has a history of hypersensitivity to Angiotensin Ⅱ receptor blocker or HMG-CoA reductase inhibitor or component of this drug
研究组 & 干预措施
HL-040XC
Experimental
Once daily, administered orally, 8 week
干预措施: HL-040XC (Drug)
Atorvastatin
Active Comparator
Once daily, administered orally, 8 week
干预措施: Atorvastatin (Drug)
Losartan
Active Comparator
Once daily, administered orally, 8 week
干预措施: Losartan (Drug)
Placebo
Placebo Comparator
Once daily, administered orally, 8 week
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline to 8 week in SiDBP (Sitting Diastolic Blood Pressure)
时间窗: Baseline and 8 week
Percent change from baseline to 8 week in LDL-Cholesterol
时间窗: Baseline and 8 week
次要结局
- Percentage of patients reaching treatment goals according to NCEP ATP III Guideline and Blood Pressure Responder according to JNC VII Guideline.(Baseline and 4, 8 week)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
2 期
A Study of HLX07 + HLX10 With or Without Chemotherapy Versus HLX10 With Chemotherapy in First Line sqNSCLCSquamous Non-small-cell Lung CancerNCT04976647Shanghai Henlius Biotech156
终止
3 期
Efficacy and Safety of ALXN1840 Administered for 48 Weeks Versus Standard of Care in Participants With Wilson DiseaseWilson DiseaseNCT03403205Alexion Pharmaceuticals, Inc.214
已完成
1 期
Evaluate the Safety and Efficacy of HLX04-O in Subjects With wAMDAge Related Macular DegenerationNCT04993352Shanghai Henlius Biotech20
已完成
3 期
Efficacy and Safety of Combination of Rosuvastatin and Ezetimibe in Patients With Primary HypercholesterolemiaPrimary HypercholesterolemiaNCT03571087Hanlim Pharm. Co., Ltd.374
已完成
2 期
Phase II Study of HMPL-004 in Patients With Ulcerative ColitisUlcerative ColitisNCT00659802Hutchison Medipharma Limited224