HyperlipidemiaPhase 1NCT01406431
Pharmacokinetic Study of Livalo® Fixed Combination Drug in Healthy Subjects
A Phase 1 study testing Pitavastatin, Valsartan and Livalo® fixed combination drug in people with Hyperlipidemia and Hypertension, run by JW Pharmaceutical at 1 site in South Korea.
Trial summary
The purpose of this study is to compare pharmacokinetics between Pitavastatin and Valsartan co-administration and Livalo fixed combination drug in healthy male subjects. Read more about this study
- Who is it for?
- Ages 20 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hyperlipidemia, Hypertension
- What is being tested?
- Pitavastatin, Valsartan and Livalo® fixed combination drug
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2011to Oct 2012
- 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 20 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male volunteers
- Age 20-55 years at the time of Screening
- BMI 19-26 kg/m2 at the time of Screening
Who cannot join
- Received other investigational drug within 90 days prior to the first dose of study drug
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Dose, Sequence-randomized, Open-label, 2x2 Crossover Study to Compare Pharmacokinetics Between Pitavastatin and Valsartan Co-administration and Livalo® Fixed Combination Drug in Healthy Male Subjects
The purpose of this study is to compare pharmacokinetics between Pitavastatin and Valsartan co-administration and Livalo fixed combination drug in healthy male subjects.
- Conditions
- Hyperlipidemia, Hypertension
- Being tested
- Pitavastatin, Valsartan, Livalo® fixed combination drug
- Keywords
- pitavastatin, Livalo
- Medical subject headings
- Hyperlipidemias, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pitavastatin, ValsartanDrug
Also called Livalo, Diovan
Pitavastatin 4mg(2 tablets), Valsartan 160mg(1 tablet)
Livalo® fixed combination drugDrug
Also called Livalo, Diovan
Livalo® fixed combination drug(1 tablet)
| Study group | Role | What they receive |
|---|---|---|
| Pitavastatin + Valsartan | Active comparator | Intervention: Drug: Pitavastatin, Valsartan Receives: Drug: Pitavastatin, Valsartan |
| Livalo fixed combination drug | Experimental | Intervention: Drug: Livalo® fixed combination drug Receives: Drug: Livalo® fixed combination drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of study drugs after single oral administration
Measured: 0-48hrs
AUClast of study drugs after single oral administration
Measured: 0-48hrs
Secondary outcomes (1)
AUCinf, Tmax and t1/2β of study drugs after single oral administration
Measured: 0-48hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionAug 2011
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipidemiaStudies 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- JW Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kyun Seop Bae, MD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01406431
- Sponsor's protocol ID
- JW-PTV-102
- Status last verified
- Jan 2013
- First submitted
- 26 Jul 2011
- Last updated
- 3 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Dose, Sequence-randomized, Open-label, 2x2 Crossover Study to Compare Pharmacokinetics Between Pitavastatin and Valsartan Co-administration and Livalo® Fixed Combination Drug in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01406431
- Acronym / sponsor ID
- JW-PTV-102
- Conditions
- Hyperlipidemia, Hypertension
- Keywords
- pitavastatin, Livalo
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- JW PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 1 Aug 2011 (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 compare pharmacokinetics between Pitavastatin and Valsartan co-administration and Livalo fixed combination drug in healthy male subjects.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pitavastatin + Valsartan | Active comparator | Drug: Pitavastatin, ValsartanIntervention: Drug: Pitavastatin, Valsartan |
| Livalo fixed combination drug | Experimental | Drug: Livalo® fixed combination drugIntervention: Drug: Livalo® fixed combination drug |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male volunteers
- Age 20-55 years at the time of Screening
- BMI 19-26 kg/m2 at the time of Screening
Key exclusion criteria (1 listed)
- Received other investigational drug within 90 days prior to the first dose of study drug
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 |
|---|---|---|
| Pitavastatin, ValsartanAlso: Livalo, DiovanPitavastatin 4mg(2 tablets), Valsartan 160mg(1 tablet) | Drug | Pitavastatin + Valsartan |
| Livalo® fixed combination drugAlso: Livalo, DiovanLivalo® fixed combination drug(1 tablet) | Drug | Livalo fixed combination drug |
Primary outcome
Cmax of study drugs after single oral administration
Time frame: 0-48hrs
AUClast of study drugs after single oral administration
Time frame: 0-48hrs
1 secondary outcome
AUCinf, Tmax and t1/2β of study drugs after single oral administration
Time frame: 0-48hrs
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 3 Jan 2013.
Related trials for Hyperlipidemia
Not yet recruiting
Plasma Lipids-Dependent Vitamin E Metabolism During Dynamic Hyperlipidemia
Lipid Metabolism Disorders
Active, not recruiting
Developing a Learning COmmunity to Increase eNgagemeNt and Enrollment in Cardiovascular Clinical Trials (CONNECT)
Cardiovascular Diseases, Hypertension
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia
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.
Kyun Seop Bae, MD principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pitavastatin, Valsartan and Livalo® fixed combination drug in people with Hyperlipidemia and Hypertension, run by JW Pharmaceutical 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 1 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 3 Jan 2013. 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 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?
Cmax of study drugs after single oral administration (time frame: 0-48hrs). 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 3 Jan 2013.