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OpenTrials
Completed

NCT Number: NCT02433119

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

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Gachon University Gil Hospital

Incheon, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OROSARTAN® 5/160mg

Drug

CODIOVAN® 160/12.5mg

Drug

Primary outcomes

  1. Change from baseline in Mean Sitting Diastolic Blood Pressure (MSDBP)

    Time frame: Baseline, Week 8

Secondary outcomes

  1. Change from baseline in MSDBP

    Time frame: Baseline, Week 4

  2. Change from baseline in Mean Sitting Systolic Blood Pressure (MSSBP)

    Time frame: Baseline, Week 4 and 8

  3. Control rate in blood pressure

    Time frame: Baseline, Week 8

    Rate of patients who achieved target blood pressure(MSDBP<90mmHg and MSSBP<140mmHg)

  4. Responder rate in blood pressure

    Time frame: Baseline, Week 8

    Rate of patients who achieved MSDBP≥10mmHg and MSSBP≥20mmHg decrease compared to baseline

Sponsors and collaborators

Lead sponsor

Dong-A ST Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
May 4, 2015
Registry last updated
Apr 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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