NL-OMON30046已完成3 期
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 - A long term comparasion in DM II patients and Combined Dyslipidemia.
Kowa Research Europe0 个研究点目标入组 50 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •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.
排除标准
- •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
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