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
Trial Locations
- Locations (1)
Sevrance Hospital
🇰🇷Seoul, Korea, Republic of