Efficacy and Safety of HL-040XC in Essential Hypertension and Hyperlipidemia
Phase 3
Completed
- Conditions
- Essential HypertensionHyperlipidemia
- Interventions
- Registration Number
- NCT01541943
- Lead Sponsor
- HanAll BioPharma Co., Ltd.
- Brief Summary
The purpose of this study is to evaluate efficacy and safety of HL-040XC in patients with essential hypertension and hyperlipidemia
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 356
Inclusion Criteria
- Aged between 18 and 80 years
- History of essential hypertension and hyperlipidemia
- Able to sign informed consent
Exclusion Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description HL-040XC HL-040XC Once daily, administered orally, 8 week Placebo Placebo Once daily, administered orally, 8 week Atorvastatin Atorvastatin Once daily, administered orally, 8 week Losartan Losartan Once daily, administered orally, 8 week
- Primary Outcome Measures
Name Time Method Change from baseline to 8 week in SiDBP (Sitting Diastolic Blood Pressure) Baseline and 8 week Percent change from baseline to 8 week in LDL-Cholesterol Baseline and 8 week
- Secondary Outcome Measures
Name Time Method 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
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie HL-040XC's dual action on angiotensin II and HMG-CoA reductase in essential hypertension and hyperlipidemia?
How does the Phase 3 efficacy of HL-040XC compare to monotherapies with losartan and atorvastatin in patients with comorbid hypertension and hyperlipidemia?
Are there specific biomarkers for predicting response to fixed-dose combination therapy with losartan and atorvastatin in NCT01541943?
What adverse event profiles distinguish HL-040XC from standard-of-care losartan and atorvastatin in Phase 3 trials for essential hypertension and hyperlipidemia?
What are the competitive advantages of HanAll BioPharma's HL-040XC over other fixed-dose antihypertensive and lipid-lowering combination therapies in clinical development?
Trial Locations
- Locations (1)
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of