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

Primary Purpose

Hypertension, Dyslipidemia

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
pitavastatin, valsartan, placebo
Sponsored by
JW Pharmaceutical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring phase III combination study

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Chungbuk National University Hospital
  • Konyang University Hospital
  • Asan Medical Center
  • Gangnam Severance Hospital
  • Hallym University Medical Center
  • Korea University Guro Hospital
  • Samsung Medical Center
  • Seoul National University Hospital
  • Severance Hospital
  • Ajou University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Placebo Comparator

Placebo Comparator

Arm Label

pitavastatin + valsartan

pitavastatin + placebo

valsartan + placebo

placebo

Arm Description

Outcomes

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.

Secondary Outcome Measures

Change from Baseline in Systolic Blood Pressure at 6 months.
The changes and rate of lipid variables (TG, TC, HDL cholesterol and apolipoprotein B)

Full Information

First Posted
July 14, 2011
Last Updated
May 12, 2014
Sponsor
JW Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT01402843
Brief Title
Efficacy, Safety of Coadministered Pitavastatin and Valsartan in Patients With Hypertension and Dyslipidemia
Acronym
COCTAIL
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)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
JW Pharmaceutical

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Dyslipidemia
Keywords
phase III combination study

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
pitavastatin + valsartan
Arm Type
Experimental
Arm Title
pitavastatin + placebo
Arm Type
Placebo Comparator
Arm Title
valsartan + placebo
Arm Type
Placebo Comparator
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
pitavastatin, valsartan, placebo
Other Intervention Name(s)
Livalo, Diovan
Intervention Description
pitavastatin 4mg/day 8 week valsartan 320mg/day 8 week
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Change from Baseline in Systolic Blood Pressure at 6 months.
Time Frame
8 week
Title
The changes and rate of lipid variables (TG, TC, HDL cholesterol and apolipoprotein B)
Time Frame
8 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients aged 20 and older Patients with Dyslipidemia Patients with hypertension Patients who voluntarily signed the consent form. Exclusion Criteria: 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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gyu Rok Han, MD
Organizational Affiliation
Dept. of Cardiology, Hallym University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chungbuk National University Hospital
City
Chung Ju
Country
Korea, Republic of
Facility Name
Konyang University Hospital
City
Daejeon
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Gangnam Severance Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Hallym University Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Korea University Guro Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Severance Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Ajou University Medical Center
City
Suwon
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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