The Efficacy and Safety of OROSARTAN® Versus CODIOVAN® in Patients With Essential Hypertension Uncontrolled With Monotherapy

Overview

A multi-center, randomized, double-blind, phase IV clinical trial to compare the efficacy and safety of OROSARTAN® tablet 5/160mg versus CODIOVAN® tablet 160/12.5mg in patients with essential hypertension uncontrolled with valsartan 160mg monotherapy

Full Title of Study: “A Multi-center, Randomized, Double-blind, Phase IV Clinical Trial to Compare the Efficacy and Safety of OROSARTAN® Tablet 5/160mg Versus CODIOVAN® Tablet 160/12.5mg in Patients With Essential Hypertension Uncontrolled With Valsartan 160mg Monotherapy”

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 8, 2016

Interventions

  • Drug: OROSARTAN® 5/160mg
  • Drug: CODIOVAN® 160/12.5mg

Arms, Groups and Cohorts

  • Experimental: Amlodipine orotate & Valsartan
    • Amlodipine orotate 6.91mg (5mg as amlodipine) and Valsartan 160 mg, tablet, once a day for 8 weeks
  • Active Comparator: Valsartan & Hydrochlorothiazide
    • Valsartan 160mg and Hydrochlorothiazide 12.5mg, tablet, once a day for 8 weeks

Clinical Trial Outcome Measures

Primary Measures

  • Change from baseline in Mean Sitting Diastolic Blood Pressure (MSDBP)
    • Time Frame: Baseline, Week 8

Secondary Measures

  • Change from baseline in MSDBP
    • Time Frame: Baseline, Week 4
  • Change from baseline in Mean Sitting Systolic Blood Pressure (MSSBP)
    • Time Frame: Baseline, Week 4 and 8
  • Control rate in blood pressure
    • Time Frame: Baseline, Week 8
    • Rate of patients who achieved target blood pressure(MSDBP<90mmHg and MSSBP<140mmHg)
  • Responder rate in blood pressure
    • Time Frame: Baseline, Week 8
    • Rate of patients who achieved MSDBP≥10mmHg and MSSBP≥20mmHg decrease compared to baseline

Participating in This Clinical Trial

Inclusion Criteria

  • 19 aged or over – A patient who was diagnosed with essential hypertension at screening(Visit 1) – A patient understood objective of this clinical trial and gave their written informed consent voluntarily Exclusion Criteria:

  • A patient with severe hypertension(MSSBP≥200mmHg or MSDBP≥120mmHg) at Visit 1 – A subject with difference(as MSSBP≥20mmHg or MSDBP≥10mmHg) in blood pressure between right and left arm at screening evaluation – Medical history or evidence of a secondary form of hypertension – A subject with history of hypersensitivity to CCB(Calcium Channel Blocker), ARB(Angiotensin II Receptor Blocker) or sulfonamide

Gender Eligibility: All

Minimum Age: 19 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Dong-A ST Co., Ltd.
  • Provider of Information About this Clinical Study
    • Sponsor

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