Evaluate the Efficacy and Safety of Combination Treatment With DW1501-R1+DW1501-R2 Versus DW1501-R1 or DW1501-R2+DW1501-R3 in Patients With Hypertension and Dyslipidemia
Phase 3
Completed
- Conditions
- DyslipidemiaHypertension
- Interventions
- Registration Number
- NCT03210532
- Lead Sponsor
- Daewon Pharmaceutical Co., Ltd.
- Brief Summary
A Multicenter, Randomized, Double-blinded, Double-dummy, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of Combination Treatment with DW1501-R1+DW1501-R2 Versus DW1501-R1 or DW1501-R2+DW1501-R3 in Patients with Hypertension and Dyslipidemia
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 129
Inclusion Criteria
- Adults both male and female who are ≥19,<80 years old
- at screening, 140mmHg≤ SBP<180mmHg & 90mmHg≤ DBP<110mmHg & LDL-C≤250mg/dL & triglyceride<400mg/dL
Exclusion Criteria
- at screening, the difference BP of one-side arm is SBP ≥ 20mmHg and DBP ≥ 10mmHg
- secondary hypertension or secondary dyslipidemia
- patients who have uncontrolled diabetes melitus, hyper/hypothyroidism or cardiac disease
- women who are pregnant or lactating
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Reference 1 Telmisartan + Rosuvastatin qd PO, Micardis(telmisartan) + Crestor(rosuvastatin) Reference 2 Telmisartan + Amlodipine qd PO,Twynsta(telmisartan/amlodipine) Test Telmisartan + Amlodipine + Rosuvastatin qd PO, Twynsta(telmisartan/amlodipine) + Crestor(rosuvastatin)
- Primary Outcome Measures
Name Time Method Change of MSSBP(Mean Sit Systolic Blood Pressure) from baseline 8-week Change of LDL-C(Low Density Lipid Cholesterol) from baseline 8-week
- Secondary Outcome Measures
Name Time Method
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 the synergistic effects of telmisartan (ARB) and rosuvastatin (statin) on angiotensin II receptor and HMG-CoA reductase in hypertension-dyslipidemia patients?
How does the efficacy of telmisartan+amlodipine (CCB) compare to standard-of-care combinations for managing hypertension and dyslipidemia in Phase 3 trials?
Which biomarkers predict response to telmisartan-based triple therapy (Telmisartan+amlodipine+rosuvastatin) in patients with comorbid hypertension and dyslipidemia?
What are the potential adverse events and management strategies for concurrent telmisartan, amlodipine, and rosuvastatin use in hypertension-dyslipidemia patients?
Are there alternative combination therapies targeting angiotensin II and lipid metabolism for hypertension and dyslipidemia, and how do they compare to Daewon's regimen?
Trial Locations
- Locations (1)
Sevrance Hospital
🇰🇷Seoul, Korea, Republic of
Sevrance Hospital🇰🇷Seoul, Korea, Republic of