HypertensionPhase 3NCT02145104
Efficacy/Safety of Cilnidipine Plus Valsartan Versus Valsartan in Patients With Hypertension
A Phase 3 study testing valsartan 160mg, cilnidipine 10mg, cilinidipine 5mg in people with Hypertension, run by IlDong Pharmaceutical Co Ltd at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate of efficacy and safety of cilinidipine plus valsartan and valsartan alone in patients with essential hypertension inadequately controlled on valsartan monotherapy Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Hypertension
- What is being tested?
- valsartan 160mg, cilnidipine 10mg, cilinidipine 5mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 286 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 Jun 2014to 29 Sep 2016
- Phase
- Phase 3
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- essential hypertension patients whose blood pressure is not controlled before the study (sDBP≥90mmHg for drug-treated patients, sDBP≥95mmHg for drug-naive patients)
Who cannot join
- sSBP≥80mmHg after 4weeks of valsartan 160mg treatment
- has a history of hypersensitivity to dihydropyridines or angiotensin II receptor blockers
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Kyung-gi
About this study
Official title: Comparison of the Efficacy and Safety of Cilnidipine 10mg/Valsartan 160mg Combination Therapy, Cilnidipine 5mg/Valsartan 160mg Combination Therapy and Valsartan 160mg Monotherapy in Hypertensive Patients Inadequately Controlled With Valsartan 160mg Monotherapy: a Multicenter, Randomized, Double Blind Phase III Study
The purpose of this study is to evaluate of efficacy and safety of cilinidipine plus valsartan and valsartan alone in patients with essential hypertension inadequately controlled on valsartan monotherapy
- Conditions
- Hypertension
- Being tested
- valsartan 160mg, cilnidipine 10mg, cilinidipine 5mg
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
valsartan 160mg, cilnidipine 10mg, cilinidipine 5mgDrug
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | cilinidpine 10mg + valsartan 160mg Receives: Drug: valsartan 160mg, cilnidipine 10mg, cilinidipine 5mg |
| Arm B | Experimental | cilnidipine 5mg + valsartan 160mg Receives: Drug: valsartan 160mg, cilnidipine 10mg, cilinidipine 5mg |
| Arm C | Active comparator | valsartan 160mg Receives: Drug: valsartan 160mg, cilnidipine 10mg, cilinidipine 5mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline in mean sDBP
Measured: 8 weeks
Secondary outcomes (2)
change from baseline in mean sDBP
Measured: 4 weeks
change from baseline in mean sSBP
Measured: 4, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2014 (estimated)
- Study start17 Jun 2014
- Primary completion7 Jun 2016
- Study completion29 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 286 participants (actual)
Sponsor and investigators
- Lead sponsor
- IlDong Pharmaceutical Co Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dong Ju Choi, M.D., Ph.D., Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02145104
- Sponsor's protocol ID
- ID_IDCV_1302
- Status last verified
- Jun 2018
- First submitted
- 20 May 2014
- Last updated
- 13 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy and Safety of Cilnidipine 10mg/Valsartan 160mg Combination Therapy, Cilnidipine 5mg/Valsartan 160mg Combination Therapy and Valsartan 160mg Monotherapy in Hypertensive Patients Inadequately Controlled With Valsartan 160mg Monotherapy: a Multicenter, Randomized, Double Blind Phase III Study
- ClinicalTrials.gov ID
- NCT02145104
- Acronym / sponsor ID
- ID_IDCV_1302
- Conditions
- Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 286 participants (actual)
- Lead sponsor
- IlDong Pharmaceutical Co LtdIndustry (pharma, biotech, devices)
- Study start
- 17 Jun 2014 (actual)
- Primary completion
- 7 Jun 2016 (actual)
- Study completion
- 29 Sep 2016 (actual)
- First posted
- 22 May 2014 (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.
The purpose of this study is to evaluate of efficacy and safety of cilinidipine plus valsartan and valsartan alone in patients with essential hypertension inadequately controlled on valsartan monotherapy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: valsartan 160mg, cilnidipine 10mg, cilinidipine 5mgcilinidpine 10mg + valsartan 160mg |
| Arm B | Experimental | Drug: valsartan 160mg, cilnidipine 10mg, cilinidipine 5mgcilnidipine 5mg + valsartan 160mg |
| Arm C | Active comparator | Drug: valsartan 160mg, cilnidipine 10mg, cilinidipine 5mgvalsartan 160mg |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- essential hypertension patients whose blood pressure is not controlled before the study (sDBP≥90mmHg for drug-treated patients, sDBP≥95mmHg for drug-naive patients)
Key exclusion criteria (2 listed)
- sSBP≥80mmHg after 4weeks of valsartan 160mg treatment
- has a history of hypersensitivity to dihydropyridines or angiotensin II receptor blockers
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 |
|---|---|---|
| valsartan 160mg, cilnidipine 10mg, cilinidipine 5mg | Drug | Arm A, Arm B, Arm C |
Primary outcome
change from baseline in mean sDBP
Time frame: 8 weeks
2 secondary outcomes
change from baseline in mean sDBP
Time frame: 4 weeks
change from baseline in mean sSBP
Time frame: 4, 8 weeks
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 13 Jun 2018.
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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.
Dong Ju Choi, M.D., Ph.D. principal investigator
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing valsartan 160mg, cilnidipine 10mg, cilinidipine 5mg in people with Hypertension, run by IlDong Pharmaceutical 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 1 inclusion and 2 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 13 Jun 2018. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 sDBP (time frame: 8 weeks). 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 13 Jun 2018.