Study to Evaluate the Safety and Efficacy of CJ-30060 in Hypertensive Patients With Hyperlipidemia

Overview

To evaluate the safety and efficacy of CJ-30060 compared with amlodipine/valsartan combination therapy and valsartan/rosuvastatin combination therapy in hypertensive patients with hyperlipidemia

Full Title of Study: “A Double-blind, Randomized, Multi-center Phase III Clinical Trial to Evaluate the Safety and Efficacy of CJ-30060 Compared With Amlodipine/Valsartan Combination Therapy and Valsartan/Rosuvastatin Combination Therapy in Hypertensive Patients With Hyperlipidemia”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: September 4, 2017

Interventions

  • Drug: Amlodipine 10 mg + Valsartan 160 mg + Rosuvastatin 20 mg
  • Drug: Amlodipine 10 mg + Valsartan 160 mg
  • Drug: Valsartan 160 mg + Rosuvastatin 20 mg

Arms, Groups and Cohorts

  • Experimental: Test
    • Amlodipine 10mg + Valsartan 160mg + Rosuvastatin 20mg
  • Active Comparator: Reference 1
    • Amlodipine 10mg + Valsartan 160mg
  • Active Comparator: Reference 2
    • Valsartan 160mg + Rosuvastatin 20mg

Clinical Trial Outcome Measures

Primary Measures

  • Change of LDL-C and siSBP
    • Time Frame: baseline and 8 weeks
    • Mean change from baseline in LDL-C and siSBP at Week 8

Participating in This Clinical Trial

Inclusion Criteria

  • Aged between 19 and 74 years – Patient with dyslipidemia and hypertension Exclusion Criteria:

  • At screening, siSBP ≥ 200 mmHg or siDBP ≥ 120mmHg or LDL-C > 250mg/dL or TG ≥ 400mg/dL – At screening, siSBP difference is ≥ 20 mmHg or siDBP difference is ≥10 mmHg – Secodary hypertension – Type I or uncontrolled diabetes mellitus (HbA1c ≥ 9 %)

Gender Eligibility: All

Minimum Age: 19 Years

Maximum Age: 74 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • HK inno.N Corporation
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Dong Ju Choi, Ph.D, Principal Investigator, Seoul National University Bundang Hospital

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