OPEN-LABEL, LONG TERM (1 YEAR) EXTENSION STUDY OF PITAVASTATIN 4MG QD IN PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA OR COMBINED DYSLIPIDEMIA

• Conditions: Patients with hypercholestrolemia or combined dyslipidemia; MedDRA version: 8.1Level: LLTClassification code 10020604

• Registration Number: EUCTR2005-001112-41-FI
• Lead Sponsor: Kowa Research Europe Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01-24
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1400

Inclusion Criteria

1). Patients have completed 12 weeks of treatment in Study NK-104-301 or NK-104-302;
2). Males and females (age 18-75 years at the start of the core study). Non-pregnant, non-lactating females;
3). Patients who have not developed any treatment emergent and in the opinion of the investigator related, AE of clinical significance where the investigator is uncomfortable with continuing the patient on therapy with pitavastatin.
4). Women of child bearing potential are allowed to enter the study ONLY if they use sustained contraceptive preparations (e.g., implants or intramuscular [IM] injections) or comply with an approved mechanical contraceptive method. A woman is considered to be of childbearing potential unless she is post-hysterectomy or at least 1-year post-menopausal or post-tubal ligation. All women of child bearing potential must have a negative pregnancy test at the end of the core study (NK-104-301 or NK-104-302);
5). Patients who are eligible and able to participate in the study and who have given written informed consent after the purpose and nature of the investigation has been explained to them;
6). Patients who have been following a fat and cholesterol restrictive diet as advised by the EAS during the dietary stabilization lead-in period before the start of the core study and through-out the entire core study (NK-104-301 or NK-104-302); and
7). Patients who agree to be available for every clinic visit, which will occur in the morning.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1). Any conditions which may cause secondary dyslipidemia, should be reassessed at the beginning of the follow-on study. This includes, but is not restricted to alcoholism, auto-immune disease, nephrotic syndrome, uremia, any viral or non viral hepatitis clinically active within 12 months from study entry, obstructive hepatic or biliary disease, dys- or macroglobulinemia, multiple myeloma, glycogen storage disease, chronic pancreatitis, porphyria, and uncontrolled hypothyroidism or hyperthyroidism (controlled hypo- or hyperthyroidism, [i.e., condition presenting with normal baseline serum thyroid stimulating hormone {TSH} and treatment stable during at least the last 2 months prior to study entry] will be permitted);
2). Uncontrolled diabetes mellitus as defined by glycosylated hemoglobin A1c (HbA1c) >8%, should be reassessed at the beginning of the follow-on study. Patients with controlled Type II diabetes are allowed, provided the disease has been stable during at least the last 3 months prior to study entry;
3). Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of any drug. The investigator should be guided by the evidence of any of the following: history of major gastrointestinal tract surgery e.g. gastrectomy, gastroenterostomy, or small bowel resection, gastritis, current active ulcers, gastrointestinal, or rectal bleeding. Current active or recurrent irritable bowel syndrome (IBS) or history of inflammatory bowel syndrome. Patients with a past history of IBS without symptoms for at least the last 6 months prior to the study start will be allowed to enter the study;
4). Any history of pancreatic injury or pancreatitis, or impaired pancreatic function/injury as indicated by abnormal lipase or amylase;
5). Liver injury as indicated by serum transaminase levels (ALAT/serum glutamic pyruvic transaminase [SGPT], ASAT/serum glutamic oxaloacetic transaminase
[SGOT] >1.5 x upper limit of the reference range (ULRR) between Visit 1 and Visit 3. If ALAT/SGPT and/or ASAT/SGOT is >2 x ULRR at any time point between Visit 1 (Week 0) and Visit 3 (Week 8) the patient will be immediately excluded from further study participation;
6). Impaired renal function as indicated by serum creatinine levels > 1.5 x ULRR at Visit 1 (Week 0);
7). Current obstruction of the urinary tract or difficulty in voiding due to mechanical as well as inflammatory conditions, which is likely to require intervention during the course of the study or is regarded as clinically meaningful by the investigator;
8). Serum CK >5 x ULRR without clinical explanation in the absence of conditions explaining the CK elevation the patient will be immediately excluded from further study participation;
9). Uncontrolled hypothyroidism defined as TSH > ULRR;
10). Any severe acute illness or severe trauma in the last 3 months prior to Visit 1(Week 0);
11). Evidence of symptomatic heart failure (New York Heart Association ([NYHA]) class III or IV), gross cardiac enlargement (cardiothoracic ratio >0.5); significant heart block or cardiac arrhythmia. History of uncontrolled complex ventricular arrhythmias, uncontrolled atrial fibrillation/flutter or uncontrolled supraventricular tachycardias with a ventricular response rate of > 100 beats per minute at rest. Patients whose electrophysiological instability are controlled with a pacemaker or implantable cardiac device are eligible;
12). Symptomatic cerebrovascular disease incl

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess long-term (up to 1 year) safety and tolerability of pitavastatin 4 mg once<br>daily (QD).;Secondary Objective: To assess the long-term efficacy of pitavastatin 4 mg QD on LDL-C levels and on other lipid and lipoprotein fractions (TC, HDL-C, TC:HDL-C ratio, TG, apolipoprotein A1 and B [Apo-A1, Apo-B]), hs-CRP, oxidized LDL and LDL-C target attainment (European Atherosclerosis Society [EAS] and National Cholesterol Education Program [NCEP]).;Primary end point(s): Long term safety and tolerability of Pitavastatin 4 mg QD is assessed for a period of up to 1 year.