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
Overview
- Phase
- Phase 3
- Intervention
- Amlodipine/Olmesartan 10/40mg (Combination drug), Rosuvastatin 20mg
- Conditions
- Hypertension
- Sponsor
- Daewoong Pharmaceutical Co. LTD.
- Enrollment
- 265
- Locations
- 1
- Primary Endpoint
- the change of LDL-C based on baseline between Treatment arm and control2 arm
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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
Investigators
Eligibility Criteria
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
Arms & Interventions
Amlodpine, Olmesartan, Rosuvastatin
co-administration of Olmesartan, Amlodipine and Rosuvastatin
Intervention: Amlodipine/Olmesartan 10/40mg (Combination drug), Rosuvastatin 20mg
Olmesartan, Rosuvastatin
co-administration of Olmesartan and Rosuvastatin
Intervention: Olmesartan 40 mg, Rosuvastatin 20mg
Amlodipine, Olmesartan
co-administration of Amlodipine and and Olmesartan
Intervention: Amlodipine/Olmesartan 10/40mg (Combination drug)
Outcomes
Primary Outcomes
the change of LDL-C based on baseline between Treatment arm and control2 arm
Time Frame: 8 weeks
the change of sitSBP based on baseline between Treatment arm and control 1 arm
Time Frame: 8 weeks