A Clinical Trial to Evaluate the Efficacy and Safety of Olmesartan/Amlodipine/Rosuvastatin Combination Treatment in Patients With Concomitant Hypertension and Hyperlipidemia
Phase 3
Completed
- Conditions
- HyperlipidemiasHypertension
- Interventions
- Drug: Amlodipine/Olmesartan 10/40mg (Combination drug), Rosuvastatin 20mgDrug: Amlodipine/Olmesartan 10/40mg (Combination drug)
- Registration Number
- NCT03009487
- Lead Sponsor
- Daewoong Pharmaceutical Co. LTD.
- Brief Summary
A multi-center, randomized, double-blind, phase III clinical trial to evaluate the efficacy and safety of Olmesartan/Amlodipine/Rosuvastatin combination treatment in patients with concomitant hypertension and hyperlipidemia
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 265
Inclusion Criteria
- Age 20 to 80 years
- patients with hypertension and hyperlipidemias
Exclusion Criteria
- orthostatic hypotension
- History of ventricular tachycardia, atrial fibrillation
- uncontrolled diabetes mellitus
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Olmesartan, Rosuvastatin Olmesartan 40 mg, Rosuvastatin 20mg co-administration of Olmesartan and Rosuvastatin Amlodpine, Olmesartan, Rosuvastatin Amlodipine/Olmesartan 10/40mg (Combination drug), Rosuvastatin 20mg co-administration of Olmesartan, Amlodipine and Rosuvastatin Amlodipine, Olmesartan Amlodipine/Olmesartan 10/40mg (Combination drug) co-administration of Amlodipine and and Olmesartan
- Primary Outcome Measures
Name Time Method the change of LDL-C based on baseline between Treatment arm and control2 arm 8 weeks the change of sitSBP based on baseline between Treatment arm and control 1 arm 8 weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Seoul national university bundang hospital
🇰🇷Seoul, Korea, Republic of