HypertensionPhase 3COCTAILNCT01402843
Efficacy, Safety of Coadministered Pitavastatin and Valsartan in Patients With Hypertension and Dyslipidemia
A Phase 3 study of Hypertension and Dyslipidemia, run by JW Pharmaceutical at 10 sites in South Korea.
Trial summary
Pitavastatin, a representative statin-series anti-dyslipidemic drug, and Valsartan, a representative ARB-series anti-hypertensive drug, have been authorized for use also in South Korea. They have been tested in many countries and proved to be effective and safe. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hypertension, Dyslipidemia
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 10 sitesSouth Korea
- Study dates
- Jun 2011to Jan 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 20 and older
- Patients with Dyslipidemia
- Patients with hypertension
- Patients who voluntarily signed the consent form.
Who cannot join
- Blood Pressure
- In case there is a sitting systolic blood pressure difference of 20mmHg and over or sitting diastolic blood pressure is 10mmHg and over in selected arm.
- Patients with symptomatic orthostatic hypotension.
- Patients having the history of Secondary hypertension or suspected to be Secondary hypertension, e.g., aortic coarctation, hyperaldosteronism, renal artery stenosis, Cushing's disease, pheochromocytoma, polycystic renal disease, etc.
- Patients with severe heart diseases (NYHA class-III and IV), with ischemic heart diseases (angina pectoris and myocardial infarction) and with peripheral vascular diseases, and patients who underwent percutaneous transluminal coronary angioplasty (PTCA) or treatments for coronary artery bypass graft within 6 months.
- Patients with clinically significant ventricular tachycardia or atrial fibrillation or atrial flutter, and patients with arrhythmia judged to be clinically significant by investigators.
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- Patients with hypertrophic obstructive cardiomyopathy, severe obstructive CAD, aortic stenosis and hemodynamically significant aortostenosis or mitral stenosis.
- Patients with severe cerebrovascular diseases.
- Patients with severe or malignant retinosis.
- Patients with consumption diseases or autoimmune diseases or connective tissue diseases
- Patients with endocrine or metabolic diseases that are known to affect serum lipid or lipoprotein.
- Patients with uncontrollable diabetes
- Patients with uncontrollable thyroid dysfunction
- Patients who underwent treatments that may affect lipid before the clinical trial.
- Patients having the history of myopathy or rhabdomyolysis.
- Patients with severe renal disorders or hepatic disorders.
- Patients with gastrointestinal diseases that may affect drug absorption, distribution, metabolism and excretion or who underwent such operations, or patients with present active gastritis or gastrointestinal hemorrhage or proctorrhagia or active and inflammatory bowel syndrome that has occurred within 12 months.
- All of patients with chronic inflammatory diseases whereto anti-inflammatory treatments need to be applied.
- Patients having the history of drug or alcohol abuse.
- Pregnant women and/or women in the lactation period or the child-bearing period.
- Patients who are hypersensitive to Pitavastatin and Valsartan.
- Patients who have taken other investigational drugs within 3 months before undergoing the screening test for this clinical trial.
- Patients judged to be unsuitable for this clinical trial by investigators.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
South Korea10 sites
Chungbuk National University Hospital
Chungju
Konyang University Hospital
Daejeon
Asan Medical Center
Seoul
Gangnam Severance Hospital
Seoul
Hallym University Medical Center
Seoul
Korea University Guro Hospital
Seoul
Samsung Medical Center
Seoul
Seoul National University Hospital
Seoul
Severance Hospital
Seoul
Ajou University Medical Center
Suwon
About this study
Official title: A Randomized, Double Blind, Double Dummy, Placebo Controlled Phase III Trial to Evaluate the Efficacy, Safety of Coadministered Pitavastatin and Valsartan in Patients With Hypertension and Dyslipidemia(COCTAIL Study)
Pitavastatin, a representative statin-series anti-dyslipidemic drug, and Valsartan, a representative ARB-series anti-hypertensive drug, have been authorized for use also in South Korea. They have been tested in many countries and proved to be effective and safe. The concurrence of dyslipidemia and hypertension has a higher rate, hence statin-series drugs and antihypertensive drugs are simultaneously administered to such patients. The combined administration of statin-series drugs and CCB-series drugs have.
Read the detailed description
This clinical trial was conducted to evaluate the safety and effectiveness of the combined administration of Pitavastatin and Valsartan to ethnic Koreans with dyslipidemia concurrent with hypertension, as well as to research the influence on the pharmacodynamic interaction between the two drugs.
- Conditions
- Hypertension, Dyslipidemia
- Being tested
- pitavastatin, valsartan, placebo
- Keywords
- phase III combination study
- Medical subject headings
- Hypertension, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pitavastatin, valsartan, placeboDrug
Also called Livalo, Diovan
pitavastatin 4mg/day 8 week valsartan 320mg/day 8 week
| Study group | Role | What they receive |
|---|---|---|
| pitavastatin + valsartan | Experimental | Not described Receives: Drug: pitavastatin, valsartan, placebo |
| pitavastatin + placebo | Placebo comparator | Not described Receives: Drug: pitavastatin, valsartan, placebo |
| valsartan + placebo | Placebo comparator | Not described Receives: Drug: pitavastatin, valsartan, placebo |
| placebo | Placebo comparator | Not described Receives: Drug: pitavastatin, valsartan, placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The experimental group should be compared with control group in the change of DBP and LDL-C on the basis of the baseline.
Measured: 8 week
Secondary outcomes (2)
Change from Baseline in Systolic Blood Pressure at 6 months.
Measured: 8 week
The changes and rate of lipid variables (TG, TC, HDL cholesterol and apolipoprotein B)
Measured: 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2011 (estimated)
- Study startJun 2011
- Primary completionJun 2012
- Study completionJan 2013
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
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- JW Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Gyu Rok Han, MD, Principal investigator, Dept. of Cardiology, Hallym University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01402843
- Sponsor's protocol ID
- CWP-PTV-301
- Acronym
- COCTAIL
- Status last verified
- May 2014
- First submitted
- 14 Jul 2011
- Last updated
- 14 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Double Dummy, Placebo Controlled Phase III Trial to Evaluate the Efficacy, Safety of Coadministered Pitavastatin and Valsartan in Patients With Hypertension and Dyslipidemia(COCTAIL Study)
- ClinicalTrials.gov ID
- NCT01402843
- Acronym / sponsor ID
- COCTAIL / CWP-PTV-301
- Conditions
- Hypertension, Dyslipidemia
- Keywords
- phase III combination study
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- JW PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 26 Jul 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.
Pitavastatin, a representative statin-series anti-dyslipidemic drug, and Valsartan, a representative ARB-series anti-hypertensive drug, have been authorized for use also in South Korea. They have been tested in many countries and proved to be effective and safe. The concurrence of dyslipidemia and hypertension has a higher rate, hence statin-series drugs and antihypertensive drugs are simultaneously administered to such patients. The combined administration of statin-series drugs and CCB-series drugs have.
Detailed description
This clinical trial was conducted to evaluate the safety and effectiveness of the combined administration of Pitavastatin and Valsartan to ethnic Koreans with dyslipidemia concurrent with hypertension, as well as to research the influence on the pharmacodynamic interaction between the two drugs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| pitavastatin + valsartan | Experimental | Drug: pitavastatin, valsartan, placebo |
| pitavastatin + placebo | Placebo comparator | Drug: pitavastatin, valsartan, placebo |
| valsartan + placebo | Placebo comparator | Drug: pitavastatin, valsartan, placebo |
| placebo | Placebo comparator | Drug: pitavastatin, valsartan, placebo |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged 20 and older
- Patients with Dyslipidemia
- Patients with hypertension
- Patients who voluntarily signed the consent form.
Key exclusion criteria (23 listed)
- Blood Pressure
- Patients with severe heart diseases (NYHA class-III and IV), with ischemic heart diseases (angina pectoris and myocardial infarction) and with peripheral vascular diseases, and patients who underwent percutaneous transluminal coronary angioplasty (PTCA) or treatments for coronary artery bypass graft within 6 months.
- Patients with clinically significant ventricular tachycardia or atrial fibrillation or atrial flutter, and patients with arrhythmia judged to be clinically significant by investigators.
- Patients with hypertrophic obstructive cardiomyopathy, severe obstructive CAD, aortic stenosis and hemodynamically significant aortostenosis or mitral stenosis.
- Patients with severe cerebrovascular diseases.
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, valsartan, placeboAlso: Livalo, Diovanpitavastatin 4mg/day 8 week valsartan 320mg/day 8 week | Drug | pitavastatin + placebo, pitavastatin + valsartan, placebo, valsartan + placebo |
Primary outcome
The experimental group should be compared with control group in the change of DBP and LDL-C on the basis of the baseline.
Time frame: 8 week
2 secondary outcomes
Change from Baseline in Systolic Blood Pressure at 6 months.
Time frame: 8 week
The changes and rate of lipid variables (TG, TC, HDL cholesterol and apolipoprotein B)
Time frame: 8 week
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 14 May 2014.
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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.
Gyu Rok Han, MD principal investigator
Dept. of Cardiology, Hallym University Medical Center
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study of Hypertension and Dyslipidemia, run by JW Pharmaceutical at 10 sites 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 4 inclusion and 23 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 14 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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. Some participants in this study may receive a placebo. 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?
The experimental group should be compared with control group in the change of DBP and LDL-C on the basis of the baseline. (time frame: 8 week). 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 14 May 2014.