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

Hypertension Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01402843
• Other study ID #: CWP-PTV-301
• Status: Completed
• Phase: Phase 3
• First received: July 14, 2011
• Last updated: May 12, 2014
• Start date: June 2011
• Est. completion date: January 2013

Study information

• Verified date: May 2014
• Source: JW Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: January 2013
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias
• Hypertension

Intervention

Drug:
• pitavastatin, valsartan, placebo
pitavastatin 4mg/day 8 week valsartan 320mg/day 8 week

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
JW Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Change from Baseline in Systolic Blood Pressure at 6 months.		8 week	Yes
Secondary	The changes and rate of lipid variables (TG, TC, HDL cholesterol and apolipoprotein B)		8 week	Yes