OPEN-LABEL, LONG-TERM ( = 1 YEAR) EXTENSION STUDY OF PITAVASTATIN 2 MG AND 4 MG QD IN ELDERLY PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA OR COMBINED DYSLIPIDEMIA

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 800

Inclusion Criteria

1) Patients who have completed 12 weeks treatment in study NK-104-306;
2) Males and postmenopausal females (aged 65 years and older);
3) Patients who have tolerated study treatment in the core study (NK-104-306);
4) 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;
5) Patients who have been following a fat and cholesterol restrictive diet (as advised by the EAS guidelines) for a total of 18-20 weeks in their previous study and will continue this diet in the open-label study; and
6) 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) no
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 18 months from core 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 exacerbation or clinical manifestation throughout the core study will be allowed to enter the follow-on 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] >2 x upper limit of the reference range (ULRR)) 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. If serum CK is between 1.5 and 5 x ULRR a re-test will be allowed. If the repeat CK is >1.5 and < 5 x ULRR and has increased compared to the previous measurement the patient will be immediately excluded from further study participation. In cases when the repeat CK is > 1.5 and < 5 x ULRR and has decreased compared to the previous measurement the patient may be enrolled in the study after consultation and agreement between the Investigator and the sponsor’s medical representative.
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) Major surgery, during the 3 months prior to Visit 1;
12) Significant CVD such as myocardial infarction, coronary or peripheral artery angioplasty, bypass graft surgery or severe or unstable angina pectoris;
13) 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 card

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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