NL-OMON30052已完成3 期
Double-blind follow-on study of Pitavastatin (4 mg) versus Simvastatin (40 mg and 80 mg), with a single-blind extension of treatment, in patients with Primary Hypercholesterolemia or Combined Dyslipidemia and 2 or more risk factors for Coronary Heart Disease - Longterm comparison in patients with PH or CD with 2+ CV risk factors.
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
- •Participation in the previous Phase III study NK-104-304
排除标准
- •The exclusion criteria of the NK-104-304 are still valid for the NK-104-309 study.
- •Patients participating in the study must not present any of the following conditions:
- •1. Familial hypercholesterolemia;
- •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. 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;
- •4. Uncontrolled diabetes mellitus as defined by glycosylated hemoglobin A1c (HbA1c) >8%. Patients with controlled diabetes Type II are allowed, provided the disease has been stable during at least the last 3 months prior to study entry;
- •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 i
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