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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03009487

Enrollment

265

Registered

2017-01-04

Start date

2017-01-31

Completion date

2018-04-30

Last updated

2022-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperlipidemias, Hypertension

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

Interventions

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

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

DRUGOlmesartan 40 mg, Rosuvastatin 20mg

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

DRUGAmlodipine/Olmesartan 10/40mg (Combination drug)

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame
the change of sitSBP based on baseline between Treatment arm and control 1 arm	8 weeks
the change of LDL-C based on baseline between Treatment arm and control2 arm	8 weeks

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026