Double-Blind follow-on study of Pitavastatine (4mg)versus atorvastatine (20 mg and 40 mg), with a single extension of treatment in patients with type II Diabetes Mellitus and Combined Dyslipidemia
- Conditions
- high cholesterol and diabets mellitus100110821001265310013317
- Registration Number
- NL-OMON30046
- Lead Sponsor
- Kowa Research Europe
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
All patients entering this study must have satisfied inclusion criteria for the previous core study (NK-104-305) and received 12 weeks of active treatment.
The exclusion criteria of the NK-104-305 study are still valid for the NK-104-310 study.
Patients participating in the study must not present any of the following conditions:
1. Homozygous familial hypercholesterolemia (heterozygous component of familial hypercholesterolemia is acceptable for inclusion);
2. Any conditions which may cause secondary dyslipidemia. 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);
3. Uncontrolled diabetes mellitus as defined by glycosylated hemoglobin A1c (HbA1c) >7.5%.
4. 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 requiring active treatment, 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;
5. Any history of pancreatic injury or pancreatitis, or impaired pancreatic function/injury as indicated by abnormal lipase or amylase;
6. 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) over the lead in period. The ALAT/SGPT and ASAT/SGOT levels must be *1.5 x ULRR on at least 2 of the 3 evaluations between Visit 1 (Week -8/-6) and Visit 3 (Week -1) for the patient to be eligible for further study participation. If ALAT/SGPT and/or ASAT/SGOT is >2 x ULRR at any time point between Visit 1 (Week 8/-6) and Visit 3 (Week -1), the patient will be immediately excluded from further study participation;
7. Impaired renal function as indicated by serum creatinine levels >1.5 x ULRR at Visit 1 (Week -8/-6). However, if creatinine is between 1.5 and 2 x ULRR, 1 retest will be permitted at Visit 2 (Week -2), provided all other criteria are fulfilled. Serum creatinine must be *1.5 x ULRR at the retest for the patient to be eligible for further study participation. If serum creatinine is >2 x ULRR at Visit 1 (Week -8/-6), the patient will be immediately excluded from further study participation;
8. 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;
9. Serum CK >5 x ULRR. However, if at Visit 1 (Week-8/-6) serum CK is >5 x ULRR without a clinical explanation, one re-test will be allowed. If the repeat CK is >5 x ULRR in the absence of conditions explaining the
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary efficacy variable is the proportion of patients achieving the LDL-C<br /><br>target goal at Visit 4 (Week 16) for the double-blind treatment period and at<br /><br>Visit 8 (Week 44) for the single-blind treatment period.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary efficacy variables are the percent change from baseline in LDL-C,<br /><br>TC, HDL C, TC:HDL C ratio, TG, Apo A1, Apo-B, Apo-B:Apo-A1 ratio, hs CRP,<br /><br>oxidized LDL and non-HDL:HDL ratio. The baseline is defined as the mean from<br /><br>Visits 2, 3 and 4 of the core study (NK 104 304) or Visits 3, 3A and 4, from<br /><br>the core study, if Visit 3A was required as a qualifying visit.</p><br>