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Trial record 44 of 65 for:    HYDROCHLOROTHIAZIDE AND VALSARTAN

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

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ClinicalTrials.gov Identifier: NCT02433119
Recruitment Status : Completed
First Posted : May 4, 2015
Last Update Posted : April 12, 2017
Sponsor:
Information provided by (Responsible Party):
Dong-A ST Co., Ltd.

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Hypertension Drug: OROSARTAN® 5/160mg Drug: CODIOVAN® 160/12.5mg Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 238 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : March 16, 2015
Actual Primary Completion Date : September 8, 2016
Actual Study Completion Date : September 8, 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Valsartan

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



Primary Outcome Measures :
  1. Change from baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) [ Time Frame: Baseline, Week 8 ]

Secondary Outcome Measures :
  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



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02433119


Locations
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Korea, Republic of
Gachon University Gil Hospital
Incheon, Korea, Republic of
Sponsors and Collaborators
Dong-A ST Co., Ltd.

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Responsible Party: Dong-A ST Co., Ltd.
ClinicalTrials.gov Identifier: NCT02433119     History of Changes
Other Study ID Numbers: ORT_EH_IV
First Posted: May 4, 2015    Key Record Dates
Last Update Posted: April 12, 2017
Last Verified: April 2017
Additional relevant MeSH terms:
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Valsartan
Hydrochlorothiazide
Hypertension
Essential Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Diuretics
Natriuretic Agents
Sodium Chloride Symporter Inhibitors