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

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.

Study Overview

• Status: Completed
• Conditions: Hypertension; Dyslipidemia
• Intervention / Treatment: Drug: pitavastatin, valsartan, placebo

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 Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Chung Ju, Korea, Republic of
    • Chungbuk National University Hospital
  • Daejeon, Korea, Republic of
    • Konyang University Hospital
  • Seoul, Korea, Republic of
    • Seoul National University Hospital
  • Seoul, Korea, Republic of
    • Asan Medical Center
  • Seoul, Korea, Republic of
    • Samsung Medical Center
  • Seoul, Korea, Republic of
    • Gangnam Severance Hospital
  • Seoul, Korea, Republic of
    • Korea University Guro Hospital
  • Seoul, Korea, Republic of
    • Severance Hospital
  • Seoul, Korea, Republic of
    • Hallym University Medical Center
  • Suwon, Korea, Republic of
    • Ajou University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: FACTORIAL
• Masking: QUADRUPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: placebo	Drug: pitavastatin, valsartan, placebo; pitavastatin 4mg/day 8 week valsartan 320mg/day 8 week; Other Names: Livalo, Diovan
EXPERIMENTAL: pitavastatin + valsartan	Drug: pitavastatin, valsartan, placebo; pitavastatin 4mg/day 8 week valsartan 320mg/day 8 week; Other Names: Livalo, Diovan
PLACEBO_COMPARATOR: pitavastatin + placebo	Drug: pitavastatin, valsartan, placebo; pitavastatin 4mg/day 8 week valsartan 320mg/day 8 week; Other Names: Livalo, Diovan
PLACEBO_COMPARATOR: valsartan + placebo	Drug: pitavastatin, valsartan, placebo; pitavastatin 4mg/day 8 week valsartan 320mg/day 8 week; Other Names: Livalo, Diovan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The experimental group should be compared with control group in the change of DBP and LDL-C on the basis of the baseline.	8 week

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from Baseline in Systolic Blood Pressure at 6 months.	8 week
The changes and rate of lipid variables (TG, TC, HDL cholesterol and apolipoprotein B)	8 week

Collaborators and Investigators

• Sponsor: JW Pharmaceutical
• Investigators: Principal Investigator: Gyu Rok Han, MD, Dept. of Cardiology, Hallym University Medical Center

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (ACTUAL): June 1, 2012
• Study Completion (ACTUAL): January 1, 2013

Study Registration Dates

• First Submitted: July 14, 2011
• First Submitted That Met QC Criteria: July 25, 2011
• First Posted (ESTIMATE): July 26, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): May 14, 2014
• Last Update Submitted That Met QC Criteria: May 12, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: phase III combination study
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Metabolic Diseases; Lipid Metabolism Disorders; Hypertension; Dyslipidemias; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Valsartan; Pitavastatin
• Other Study ID Numbers: CWP-PTV-301