HypertensionPhase 4NCT02433119
The Efficacy and Safety of OROSARTAN® Versus CODIOVAN® in Patients With Essential Hypertension Uncontrolled With Monotherapy
A Phase 4 study testing OROSARTAN® 5/160mg and CODIOVAN® 160/12.5mg in people with Hypertension, run by Dong-A ST Co., Ltd. at 1 site in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- OROSARTAN® 5/160mg and CODIOVAN® 160/12.5mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 238 participants
- Where
- 1 siteSouth Korea
- Study dates
- 16 Mar 2015to 8 Sep 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Conditions
- Hypertension
- Being tested
- OROSARTAN® 5/160mg, CODIOVAN® 160/12.5mg
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OROSARTAN® 5/160mgDrug
CODIOVAN® 160/12.5mgDrug
| Study group | Role | What they receive |
|---|---|---|
| Amlodipine orotate & Valsartan | Experimental | Amlodipine orotate 6.91mg (5mg as amlodipine) and Valsartan 160 mg, tablet, once a day for 8 weeks Receives: Drug: OROSARTAN® 5/160mg |
| Valsartan & Hydrochlorothiazide | Active comparator | Valsartan 160mg and Hydrochlorothiazide 12.5mg, tablet, once a day for 8 weeks Receives: Drug: CODIOVAN® 160/12.5mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Mean Sitting Diastolic Blood Pressure (MSDBP)
Measured: Baseline, Week 8
Secondary outcomes (4)
Change from baseline in MSDBP
Measured: Baseline, Week 4
Change from baseline in Mean Sitting Systolic Blood Pressure (MSSBP)
Measured: Baseline, Week 4 and 8
Control rate in blood pressure
Rate of patients who achieved target blood pressure(MSDBP<90mmHg and MSSBP<140mmHg)
Measured: Baseline, Week 8
Responder rate in blood pressure
Rate of patients who achieved MSDBP≥10mmHg and MSSBP≥20mmHg decrease compared to baseline
Measured: Baseline, Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2015 (estimated)
- Study start16 Mar 2015
- Primary completion8 Sep 2016
- Study completion8 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 238 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dong-A ST Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02433119
- Sponsor's protocol ID
- ORT_EH_IV
- Status last verified
- Apr 2017
- First submitted
- 29 Apr 2015
- Last updated
- 12 Apr 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02433119
- Acronym / sponsor ID
- ORT_EH_IV
- Conditions
- Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 238 participants (actual)
- Lead sponsor
- Dong-A ST Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 Mar 2015 (actual)
- Primary completion
- 8 Sep 2016 (actual)
- Study completion
- 8 Sep 2016 (actual)
- First posted
- 4 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amlodipine orotate & Valsartan | Experimental | Drug: OROSARTAN® 5/160mgAmlodipine orotate 6.91mg (5mg as amlodipine) and Valsartan 160 mg, tablet, once a day for 8 weeks |
| Valsartan & Hydrochlorothiazide | Active comparator | Drug: CODIOVAN® 160/12.5mgValsartan 160mg and Hydrochlorothiazide 12.5mg, tablet, once a day for 8 weeks |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OROSARTAN® 5/160mg | Drug | Amlodipine orotate & Valsartan |
| CODIOVAN® 160/12.5mg | Drug | Valsartan & Hydrochlorothiazide |
Primary outcome
Change from baseline in Mean Sitting Diastolic Blood Pressure (MSDBP)
Time frame: Baseline, Week 8
4 secondary outcomes
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
Responder rate in blood pressure
Time frame: Baseline, Week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing OROSARTAN® 5/160mg and CODIOVAN® 160/12.5mg in people with Hypertension, run by Dong-A ST Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) (time frame: Baseline, Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2017.