Clinical Trial to Evaluate the Efficacy and Safety of OLOMAX Tab (Olmesartan 20 mg/Amlodipine 5 mg/Rosuvastatin 5 or 10 mg) in Hypertension Patients With Low-Intermediate Risk for Cardiovascular Disease

• Status: Unknown status
• Trial end date: 2020-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy and safety of OLOMAX Tab (20/5/5mg, 20/5/10mg) in Hypertension Patients with Low-Intermediate Risk for Cardiovascular Disease.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.
• Treatments: Amlodipine; Olmesartan; Olmesartan Medoxomil; Rosuvastatin Calcium

Criteria

Inclusion Criteria:

• Both man and woman who is over 19 years old

• Patients with hypertension

• Persons with mLDL ≥ 130mg/dL (low risk for cardiovascular disease) or mLDL ≥ 100mg/dL (intermediate risk for cardiovascular disease)

• Written informed consent

Exclusion Criteria:

• Patient with hypersensitivity Olmesartan, Amlodipine, Rosuvastatin, dihydropyridine

• Who disagreed to perform effective contraception during the clinical trial

• Orthostatic hypotension with symptoms

• Secondary hypertension and suspected secondary hypertension

• Creatinine clearance < 30mL/min

• AST(Aspartate Aminotransferase) or ALT(Alanine Aminotransferase) level ≥ 3x ULN (upper limit of normal range)