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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02433119 |
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Date of registration:
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29/04/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The Efficacy and Safety of OROSARTAN® Versus CODIOVAN® in Patients With Essential Hypertension Uncontrolled With Monotherapy
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Scientific title:
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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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Date of first enrolment:
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March 16, 2015 |
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Target sample size:
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238 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02433119 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 4
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Countries of recruitment
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Korea, Republic of
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Key inclusion & exclusion criteria
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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
Age minimum:
19 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Hypertension
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Intervention(s)
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Drug: OROSARTAN® 5/160mg
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Drug: CODIOVAN® 160/12.5mg
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Primary Outcome(s)
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Change from baseline in Mean Sitting Diastolic Blood Pressure (MSDBP)
[Time Frame: Baseline, Week 8]
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Secondary Outcome(s)
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Responder rate in blood pressure
[Time Frame: Baseline, Week 8]
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Change from baseline in Mean Sitting Systolic Blood Pressure (MSSBP)
[Time Frame: Baseline, Week 4 and 8]
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Control rate in blood pressure
[Time Frame: Baseline, Week 8]
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Change from baseline in MSDBP
[Time Frame: Baseline, Week 4]
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Secondary ID(s)
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ORT_EH_IV
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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