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

April 11, 2017 updated by: Dong-A ST Co., Ltd.

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

238

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Amlodipine orotate & Valsartan
Amlodipine orotate 6.91mg (5mg as amlodipine) and Valsartan 160 mg, tablet, once a day for 8 weeks
Drug: OROSARTAN® 5/160mg
Active Comparator: Valsartan & Hydrochlorothiazide
Valsartan 160mg and Hydrochlorothiazide 12.5mg, tablet, once a day for 8 weeks
Drug: CODIOVAN® 160/12.5mg

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dong-A ST Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 16, 2015

Primary Completion (Actual)

September 8, 2016

Study Completion (Actual)

September 8, 2016

Study Registration Dates

First Submitted

April 29, 2015

First Submitted That Met QC Criteria

April 29, 2015

First Posted (Estimate)

May 4, 2015

Study Record Updates

Last Update Posted (Actual)

April 12, 2017

Last Update Submitted That Met QC Criteria

April 11, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ORT_EH_IV

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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