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

NCT01402843 | Completed Phase 3

• 1 other identifier: CWP-PTV-301
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 10

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.

Conditions

Hypertension; Dyslipidemia

Keywords

phase III combination study

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (4)

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

Interventions

pitavastatin, valsartan, placebo DRUG

pitavastatin 4mg/day 8 week valsartan 320mg/day 8 week

Also known as: Livalo, Diovan

pitavastatin + placebo; pitavastatin + valsartan; placebo; valsartan + placebo

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 20 and older
• Patients with Dyslipidemia
• Patients with hypertension
• Patients who voluntarily signed the consent form.

You may not qualify if:

• 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.

Sponsors & Collaborators

• JW Pharmaceutical: lead

Study Sites (10)

Chungbuk National University Hospital

Chungju, South Korea

Location

Konyang University Hospital

Daejeon, South Korea

Location

Asan Medical Center

Seoul, South Korea

Location

Gangnam Severance Hospital

Seoul, South Korea

Location

Hallym University Medical Center

Seoul, South Korea

Location

Korea University Guro Hospital

Seoul, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

Severance Hospital

Seoul, South Korea

Location

Ajou University Medical Center

Suwon, South Korea

Location

MeSH Terms

Conditions

Hypertension; Dyslipidemias

Interventions

pitavastatin; Valsartan

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential

Study Officials

• Gyu Rok Han, MD

  Dept. of Cardiology, Hallym University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 14, 2011
• First Posted: July 26, 2011
• Study Start: June 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: January 1, 2013
• Last Updated: May 14, 2014

Record last verified: 2014-05

Locations

KR (10)