PER-074-07已完成未知
AN EXTENSION OF 12 MONTHS FOR: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY, TOLERABILITY AND EFFECTIVENESS OF MK-0822 (KATEATE-K INHIBITOR) IN THE TREATMENT OF POST-MENOPAUSAL WOMEN WITH OSTEOPOROSIS
MERCK SHARP & DOHME PERU S.R.L.,0 个研究点目标入组 0 人开始时间: 2007年11月5日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
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
- 0 至 0（—）
入选标准
- •The patient has met all the initial inclusion criteria and has not met any of the exclusion criteria of Protocol 004-01.
- •The patient participated and completed the 24 months of treatment in Protocol 004-01 (to be determined in V13 / Month 24).
- •The patient has, in general, good health, based on the medical history, physical examination and laboratory evaluation.
排除标准
- •• The patient has withdrawn from! Protocol 004-01 for any reason before completing the first extension (visit of month 24).
- •The patient presented fracture in the hip, spine, or other fragility fracture during the baseline study and would prefer to receive another therapy for osteoporosis (bisphosphonates or PTH) for which she is eligible.
- •The patient has used oral bisphosphonates in the last 6 months, bisphosphonates IV at any time, or has been treated with glucocorticoids (> 5 mg / day of prednisone or equivalent) for more than 2 weeks in the last 6 months.
- •The patient has used estrogen ± progestin, raloxifene or another SERM, tamoxifen, tibolone, or an aromatase inhibitor or calcitonin.
- •The patient is currently taking Vitamin A (excluding beta carotene)> 10,000 TU daily or Vitamin D> 5,000 lU daily.
- •The patient was diagnosed with primary parathyroid disease during the baseline study and has elevated PTH or a serum calcium level higher than the upper limit of normal.
- •The patient has hypocalcemia as defined as serum calcium level <8.5 mg / dL, when corrected for albumin, or shows evidence of secondary hyperparathyroidism.
- •The patient experienced during the baseline study (a) a marked prolongation of the QT / QTc interval (eg, repeated demonstration of a QTc interval> 450), or (b) additional risk factors for Torsades de Pointes (eg, heart failure, hypokalemia) or (c) concomitant use of medications that prolong the QT / QTc interval (eg, quinidine, procainamide, disopyramide, tricyclic antidepressants, phenothiazines, amiodarone, or sotalol).
- •The patient has significant clinical or laboratory abnormalities at the baseline of the extent that, in the opinion of the investigator, could complicate the interpretation of the study results or represent an additional risk to the patient (for example, patients who do not roam should be excluded for this reason).
- •The patient has cancer or has had a diagnosis of any malignancy during the baseline study, with the exception of basal or squamous cell skin cancer or cervical cancer in situ adequately treated.
- •The patient is, in the opinion of the investigator, mentally or legally incapacitated so that informed consent can not be obtained, or the patient does not know how to read or can not understand the written material.
- •The patient has participated in the study of a research drug different from Protocol 004-01 within the last 30 days.
- •The patient is currently a consumer of recreational or illicit drugs or has a recent history of drug or alcohol abuse or dependence.
- •The patient shows that she does not comply with the procedures required in the study.
研究者
相似试验
已完成
不适用
AN EXTENSION OF 12 MONTHS FOR: A RANDOMIZED, DOUBLE-BLIND, DOUBLE SIMULATOR, PARALLEL GROUP, MULTICENTRIC STUDY TO EVALUATE AND COMPARE THE EFFECTS OF ALENDRONATE AND RISEDRONATE ON BONE MINERAL DENSITY IN POSTMENUPAUSIC WOMEN WITH OSTEOPOROSIS (INTERNATIONAL FOSAMAX COMPARISON TESTS AND ACTONEL: FACT (BY ITS ACRONYMS IN ENGLISH) -INTERNATIONAL)PER-012-03MERCK SHARP & DOHME PERU S.R.L.,
已完成
不适用
A 24-MONTH EXTENSION FOR: A RANDOMIZED, DOUBLE BLIND, CONTROLLED PLACEBO STUDY TO EVALUATE THE SAFETY, TOLERABILITY AND EFFECTIVENESS OF MK-0822 (KATEPSIN-K INHIBITOR) IN THE TREATMENT OF POST-MENOPAUSE WOMEN WITH OSTE-M819M819PER-139-08MERCK SHARP & DOHME PERU S.R.L.,
进行中（未招募）
1 期
A 24-Month Extension to: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, and Efficacy of MK-0822 (Cathepsin-K Inhibitor) in the Treatment of Postmenopausal Women with Osteoporosis - Cat-K 11b Osteoporosis StudyMedDRA version: 14.1 Level: PT Classification code 10031285 Term: Osteoporosis postmenopausal System Organ Class: 10028395 - Musculoskeletal and connective tissue disordersPostmenopausal OsteoporosisEUCTR2005-001511-22-GBMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.399
进行中（未招募）
1 期
Comparison of efficacy of masitinib versus placebo in the treatment of Crohn's diseaseCrohn's diseaseEUCTR2012-004222-25-SKAB Science450
进行中（未招募）
1 期
Comparison of efficacy of masitinib versus placebo in the treatment of Crohn's diseaseMedDRA version: 18.0Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disordersCrohn's diseaseEUCTR2012-004222-25-GRAB Science450