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

Daewoong Pharmaceutical Co. LTD.265 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

265

Conditions

Hypertension Hyperlipidemias

Interventions

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

co-administration of Sevikar tab. 10/40mg(Amlodipine/Olmesartan 10/40mg), Crestor Tab. 20mg(Rosuvastatin 20mg) and placebo of Olmesartan 40mg

Olmesartan 40 mg, Rosuvastatin 20mgDRUG

co-administration of Olmetec tab. 40mg(Olmesartan 40mg), Crestor tab. 20mg(Rosuvastatin 20mg) and placebo of Sevikar Tab 10/40mg(Amlodipine/Olmesartan 10/40mg).

Amlodipine/Olmesartan 10/40mg (Combination drug)DRUG

co-administration of Sevikar tab. 10/40mg(Amlodipine/Olmesartan 10/40mg) 10/40mg, Placebo of Olmesartan Tab. 40mg and Placebo of Rosuvastatin 20mg

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Seoul national university bundang hospital

Seoul, South Korea

Outcomes

Primary Outcomes

the change of sitSBP based on baseline between Treatment arm and control 1 arm

Time frame: 8 weeks

the change of LDL-C based on baseline between Treatment arm and control2 arm

Time frame: 8 weeks

Data from ClinicalTrials.gov

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