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

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

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: April 2018

Interventions

  • Drug: Amlodipine/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
  • Drug: Olmesartan 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).
  • Drug: Amlodipine/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

Arms, Groups and Cohorts

  • Experimental: Amlodpine, Olmesartan, Rosuvastatin
    • co-administration of Olmesartan, Amlodipine and Rosuvastatin
  • Placebo Comparator: Olmesartan, Rosuvastatin
    • co-administration of Olmesartan and Rosuvastatin
  • Placebo Comparator: Amlodipine, Olmesartan
    • co-administration of Amlodipine and and Olmesartan

Clinical Trial Outcome Measures

Primary Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Daewoong Pharmaceutical Co. LTD.
  • Provider of Information About this Clinical Study
    • Sponsor

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