Evaluating the Efficacy and Safety of Co-administrated Rosuvastatin/Ezetimibe and Telmisartan/Amlodipine

Overview

The purpose of this study is to evaluate the efficacy and safety of co-administrated Rosuvastatin/Ezetimibe and Telmisartan/Amlodipine in patients with primary hypercholesterolemia and essential hypertension.

Full Title of Study: “A Randomized, Double-blind, Active-controlled, Multicenter Phase III Trial to Evaluate the Efficacy and Safety of Co-administrated AD-2071 and AD-2073 in Patients With Primary Hypercholesterolemia and Essential Hypertension”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: May 30, 2020

Detailed Description

This trial is a phase 3 study to evaluate efficacy and safety of co-administrated Rosuvastatin/Ezetimibe and Telmisartan/Amlodipine in patients with primary hypercholesterolemia and essential hypertension.

In "Rosuvastatin/Ezetimibe+Telmisartan/Amlodipine" treatment group, 48 subjects will be assigned and the subjects administer "Rosuvastatin/Ezetimibe+Telmisartan/Amlodipine" for 8 weeks.

In "Rosuvastatin/Ezetimibe +Telmisartan " treatment group, 48 subjects will be assigned and the subjects administer "Rosuvastatin/Ezetimibe+Telmisartan" for 8 weeks.

In "Telmisartan/Amlodipine" treatment group, 48 subjects will be assigned and the subjects administer "Telmisartan/Amlodipine" for 8 weeks.

Interventions

  • Drug: Ezetimibe/Rosuvastatin
    • PO, Once daily(QD), 8weeks
  • Drug: Telmisartan
    • PO, Once daily(QD), 8weeks
  • Drug: Telmisartan/Amlodipine 80 Mg-5 Mg ORAL TABLET
    • PO, Once daily(QD), 8weeks

Arms, Groups and Cohorts

  • Experimental: Co-administered of AD-2071 and AD-2073
    • 48 subjects will be assigned and the subjects will be administered “AD-2071(Ezetimibe/Rosuvastatin) and AD-2073(Telmisartan/Amlodipine)” for 8 weeks.
  • Active Comparator: Co-administered of AD-2071 and AD-2072
    • 48 subjects will be assigned and the subjects will be administered “AD-2071(Ezetimibe/Rosuvastatin) and AD-2072(Telmisartan)” for 8 weeks.
  • Active Comparator: AD-2073
    • 48 subjects will be assigned and the subjects will be administered “AD-2073(Telmisartan/Amlodipine)” for 8 weeks.

Clinical Trial Outcome Measures

Primary Measures

  • Low density lipoprotein cholesterol (LDL-C)
    • Time Frame: Baseline, Week 8
    • LDL-C change at Week 8 compared AD-2071 + AD-2073 with AD-2073
  • Mean sitting systolic blood pressure (MSSBP)
    • Time Frame: Baseline, Week 8
    • MSSBP change at Week 8 compared AD-2071 + AD-2072 with AD-2071 + AD-2073

Participating in This Clinical Trial

Inclusion Criteria

  • Signed informed consent
  • Subjects with hypertension and hyperlipidemia

Exclusion Criteria

  • Patient with known or suspected secondary hypertension
  • Other exclusions applied

Gender Eligibility: All

Minimum Age: 19 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Addpharma Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Hyo Soo Kim, M.D., Ph.D, Principal Investigator, Seoul National University Hospital
  • Overall Contact(s)
    • kyungtae kim, D.V.M, 031-891-5661, ktkim@addpharma.co.kr

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