A Clinical Trial to Evaluate the Efficacy and Safety of Olmesartan/Amlodipine/Rosuvastatin Combination Treatment in Patients With Concomitant Hypertension and Hyperlipidemia

Daewoong Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Hypertension; Hyperlipidemias

Treatments: Drug: Amlodipine/Olmesartan 10/40mg (Combination drug); Drug: Olmesartan 40 mg, Rosuvastatin 20mg; Drug: Amlodipine/Olmesartan 10/40mg (Combination drug), Rosuvastatin 20mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT03009487

DW_DWJ1351003

Details and patient eligibility

About

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

Enrollment: 265 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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265 participants in 3 patient groups, including a placebo group

Amlodpine, Olmesartan, Rosuvastatin

Experimental group

Description:

co-administration of Olmesartan, Amlodipine and Rosuvastatin

Treatment:

Drug: Amlodipine/Olmesartan 10/40mg (Combination drug), Rosuvastatin 20mg

Olmesartan, Rosuvastatin

Placebo Comparator group

Description:

co-administration of Olmesartan and Rosuvastatin

Treatment:

Drug: Olmesartan 40 mg, Rosuvastatin 20mg

Amlodipine, Olmesartan

Placebo Comparator group

Description:

co-administration of Amlodipine and and Olmesartan

Treatment:

Drug: Amlodipine/Olmesartan 10/40mg (Combination drug)