HypertensionPhase 1IDCVNCT02343250
A Bioequivalence Study Comparing Cilnidipine/Valsartan Combination With Coadministration of Cilnidipine and Valsartan
A Phase 1 study testing Cilnidipine/Valsartan and Cilnidipine+Valsartan in people with Hypertension, run by IlDong Pharmaceutical Co Ltd.
Trial summary
A Randomized, Open-label, Single Dosing, Two-way Crossover Clinical Trial to Compare the Safety/Tolerability and Pharmacokinetics of the Combination of Cilnidipine 10mg and Valsartan 160mg in Comparison to Each Component Coadministered in Healthy Male Volunteers Read more about this study
- Who is it for?
- Ages 19 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Cilnidipine/Valsartan and Cilnidipine+Valsartan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to Mar 2015
- Phase
- Phase 1
- 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 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 20 and 40
- Signed informed consent
Who cannot join
- Has a history of hypersensitivity to IP ingredients
- Hypertension of hypotension
About this study
Official title: A Randomized, Open-label, Single Dosing, Two-way Crossover Clinical Trial to Compare the Safety/Tolerability and Pharmacokinetics of the Combination of Cilnidipine 10mg and Valsartan 160mg in Comparison to Each Component Coadministered in Healthy Male Volunteers
A Randomized, Open-label, Single Dosing, Two-way Crossover Clinical Trial to Compare the Safety/Tolerability and Pharmacokinetics of the Combination of Cilnidipine 10mg and Valsartan 160mg in Comparison to Each Component Coadministered in Healthy Male Volunteers
- Conditions
- Hypertension
- Being tested
- Cilnidipine/Valsartan, Cilnidipine+Valsartan
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cilnidipine/ValsartanDrug
Cilnidipine 10mg/Valsartan 160mg oral on day1 of 14day cycle
Cilnidipine+ValsartanDrug
Cinidipine 10mg+Valsartan 160mg oral on day1 of 14day cycle
Cilnidipine/ValsartanDrug
Cilnidipine 10mg/Valsartan 160mg oral on day1 of 14day cycle
Cilnidipine+ValsartanDrug
Cinidipine 10mg+Valsartan 160mg oral on day1 of 14day cycle
| Study group | Role | What they receive |
|---|---|---|
| Cinidipine/Valsartan tablet | Experimental | Cinidipine/Valsartan tablet Receives: Drug: Cilnidipine/Valsartan; Drug: Cilnidipine+Valsartan |
| Cilnidipine+Valsartan | Active comparator | coadministration of cilinidipine and valsartan Receives: Drug: Cilnidipine+Valsartan; Drug: Cilnidipine/Valsartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUClast
Measured: 0~24hr
Cmax
Measured: 0~24hr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2015 (estimated)
- Study startMar 2015
- Primary completionMar 2015
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- IlDong Pharmaceutical Co Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kyungsang Yu, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02343250
- Sponsor's protocol ID
- ID-IDCV-103
- Acronym
- IDCV
- Status last verified
- Jan 2016
- First submitted
- 15 Jan 2015
- Last updated
- 13 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Single Dosing, Two-way Crossover Clinical Trial to Compare the Safety/Tolerability and Pharmacokinetics of the Combination of Cilnidipine 10mg and Valsartan 160mg in Comparison to Each Component Coadministered in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT02343250
- Acronym / sponsor ID
- IDCV / ID-IDCV-103
- Conditions
- Hypertension
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- IlDong Pharmaceutical Co LtdIndustry (pharma, biotech, devices)
- Study start
- Mar 2015
- Primary completion
- Mar 2015 (actual)
- First posted
- 21 Jan 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 Randomized, Open-label, Single Dosing, Two-way Crossover Clinical Trial to Compare the Safety/Tolerability and Pharmacokinetics of the Combination of Cilnidipine 10mg and Valsartan 160mg in Comparison to Each Component Coadministered in Healthy Male Volunteers
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cinidipine/Valsartan tablet | Experimental | Drug: Cilnidipine/Valsartan, Drug: Cilnidipine+ValsartanCinidipine/Valsartan tablet |
| Cilnidipine+Valsartan | Active comparator | Drug: Cilnidipine+Valsartan, Drug: Cilnidipine/Valsartancoadministration of cilinidipine and valsartan |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age between 20 and 40
- Signed informed consent
Key exclusion criteria (2 listed)
- Has a history of hypersensitivity to IP ingredients
- Hypertension of hypotension
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 |
|---|---|---|
| Cilnidipine/ValsartanCilnidipine 10mg/Valsartan 160mg oral on day1 of 14day cycle | Drug | Cinidipine/Valsartan tablet |
| Cilnidipine+ValsartanCinidipine 10mg+Valsartan 160mg oral on day1 of 14day cycle | Drug | Cilnidipine+Valsartan |
| Cilnidipine/ValsartanCilnidipine 10mg/Valsartan 160mg oral on day1 of 14day cycle | Drug | Cilnidipine+Valsartan |
| Cilnidipine+ValsartanCinidipine 10mg+Valsartan 160mg oral on day1 of 14day cycle | Drug | Cinidipine/Valsartan tablet |
Primary outcome
AUClast
Time frame: 0~24hr
Cmax
Time frame: 0~24hr
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 Jan 2016.
- Related InfoLink provided by the sponsor.
Related trials for Hypertension
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
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.
Kyungsang Yu, PhD principal investigator
Seoul National University Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cilnidipine/Valsartan and Cilnidipine+Valsartan in people with Hypertension, run by IlDong Pharmaceutical Co Ltd.
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 2 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 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
AUClast (time frame: 0~24hr). The study lists 2 primary outcomes in all. 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 Jan 2016.