Efficacy, Safety of Coadministered Pitavastatin and Valsartan in Patients With Hypertension and Dyslipidemia (COCTAIL)

This study has been completed.
Sponsor:
Information provided by:
JW Pharmaceutical
ClinicalTrials.gov Identifier:
NCT01402843
First received: July 14, 2011
Last updated: May 12, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Hypertension
Dyslipidemia
Drug: pitavastatin, valsartan, placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by JW Pharmaceutical:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from Baseline in Systolic Blood Pressure at 6 months. [ Time Frame: 8 week ] [ Designated as safety issue: Yes ]
  • The changes and rate of lipid variables (TG, TC, HDL cholesterol and apolipoprotein B) [ Time Frame: 8 week ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 150
Study Start Date: June 2011
Study Completion Date: January 2013
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: pitavastatin + valsartan Drug: pitavastatin, valsartan, placebo
pitavastatin 4mg/day 8 week valsartan 320mg/day 8 week
Other Name: Livalo, Diovan
Placebo Comparator: pitavastatin + placebo Drug: pitavastatin, valsartan, placebo
pitavastatin 4mg/day 8 week valsartan 320mg/day 8 week
Other Name: Livalo, Diovan
Placebo Comparator: valsartan + placebo Drug: pitavastatin, valsartan, placebo
pitavastatin 4mg/day 8 week valsartan 320mg/day 8 week
Other Name: Livalo, Diovan
Placebo Comparator: placebo Drug: pitavastatin, valsartan, placebo
pitavastatin 4mg/day 8 week valsartan 320mg/day 8 week
Other Name: Livalo, Diovan

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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients aged 20 and older
  2. Patients with Dyslipidemia
  3. Patients with hypertension
  4. Patients who voluntarily signed the consent form.

Exclusion Criteria:

  1. 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.
  2. 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.
  3. Patients with clinically significant ventricular tachycardia or atrial fibrillation or atrial flutter, and patients with arrhythmia judged to be clinically significant by investigators.
  4. Patients with hypertrophic obstructive cardiomyopathy, severe obstructive CAD, aortic stenosis and hemodynamically significant aortostenosis or mitral stenosis.
  5. Patients with severe cerebrovascular diseases.
  6. Patients with severe or malignant retinosis.
  7. Patients with consumption diseases or autoimmune diseases or connective tissue diseases
  8. Patients with endocrine or metabolic diseases that are known to affect serum lipid or lipoprotein.

    • Patients with uncontrollable diabetes
    • Patients with uncontrollable thyroid dysfunction
  9. Patients who underwent treatments that may affect lipid before the clinical trial.
  10. Patients having the history of myopathy or rhabdomyolysis.
  11. Patients with severe renal disorders or hepatic disorders.
  12. 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.
  13. All of patients with chronic inflammatory diseases whereto anti-inflammatory treatments need to be applied.
  14. Patients having the history of drug or alcohol abuse.
  15. Pregnant women and/or women in the lactation period or the child-bearing period.
  16. Patients who are hypersensitive to Pitavastatin and Valsartan.
  17. Patients who have taken other investigational drugs within 3 months before undergoing the screening test for this clinical trial.
  18. Patients judged to be unsuitable for this clinical trial by investigators.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01402843

Locations
Korea, Republic of
Chungbuk National University Hospital
Chung Ju, Korea, Republic of
Konyang University Hospital
Daejeon, Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Korea University Guro Hospital
Seoul, Korea, Republic of
Gangnam Severance Hospital
Seoul, Korea, Republic of
Hallym University Medical Center
Seoul, Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Ajou University Medical Center
Suwon, Korea, Republic of
Sponsors and Collaborators
JW Pharmaceutical
Investigators
Principal Investigator: Gyu Rok Han, MD Dept. of Cardiology, Hallym University Medical Center
  More Information

No publications provided

Responsible Party: Gyu Rok Han / MD, Hallym University Medical Center
ClinicalTrials.gov Identifier: NCT01402843     History of Changes
Other Study ID Numbers: CWP-PTV-301
Study First Received: July 14, 2011
Last Updated: May 12, 2014
Health Authority: Korea: Food and Drug Administration

Keywords provided by JW Pharmaceutical:
phase III combination study

Additional relevant MeSH terms:
Hypertension
Dyslipidemias
Vascular Diseases
Cardiovascular Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Valsartan
Pitavastatin
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Enzyme Inhibitors
Lipid Regulating Agents

ClinicalTrials.gov processed this record on September 18, 2014