A PHASE 3, 40-WEEK, ACTIVE-CONTROLLED, DOUBLE-BLIND EXTENSION STUDY OF PRELADENANT IN SUBJECTS WITH MODERATE TO SEVERE PARKINSON´S DISEASE (PHASE 3, PROTOCOL N° P06153)

SCHERING PLOUGH RESEARCH INSTITUTE,0 个研究点目标入组 0 人开始时间: 2011年6月2日最近更新: 2023年9月4日

试验速览

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•1. SUBJECTS MUST HAVE COMPLETED P04938 OR PO7037
•2. EACH SUBJECT (OR SUBJECT´S LEGAL REPRESENTATIVE) MUST BE WILLING AND ABLE TO PROVIDE WRITTEN INFORMED CONSENT FOR THE P06153. FOR A SUBJECT WHO IS UNABLE TO PROVIDE INDEPENDENT CONSENT, A LEGAL REPRESENTATIVE MAY PROVIDE WRITTEN INFORMED CONSENT.
•3. SUBJECTS MUST BE ABLE TO ADHERE TO DOSE AND VISIT SCHEDULES.
•4. SUBJECTS MUST BE TAKING LEVODOPA (L-DOPA).
•5. SUBJECTS MAY BE TAKING ANY OF THE ADDITIONAL ADJUNCT PD MEDICATIONS SHOWN IN TABLE 1.
•NOTE: SUBJECTS TAKING ONLY L-DOPA ARE PERMITTED TO ENROLL IN THIS TRIAL IF THEY MEET THE PREVIOUS INCLUSION CRITRION.

•1. A SUBJECT MUST NOT HAVE DISCONTINUED FROM PO4938 OR P07037 FOR ANY REASON.
•2. A SUBJECT MUST NOT HAVE A SEVERE OR ONGOING UNSTABLE MEDICAL CONDITION (eg, ANY FORM OF CLINICALLY SIGNIFICANT CARDIAC DISEASE, SYMPTOMATIC ORTHOSTATIC HYPOTENSION, SEIZURES OR ALCOHOL/DRUG DEPENDENCE).
•3. A SUBJECT MUST NOT HAVE POORLY CONTROLLED DIABETES (eg, HbA1c> 8.5) OR SIGNIFICANTLY ABNORMAL RENAL FUNCTION (eg, CREATININE> 2.0 MG/DL) IN THE OPINION OF THE INVESTIGATOR.
•4. AS A CONTlNUED OF THE LIVER-RELATED WITHDRAWAL CRITERIA FROM THE PARENT STUDIES (P04938 AND P07037), ANY SUBJECT WITH ELEVATED VALUES FOR ALANINE AMINOTRANSFERASE (ALT), ASPARTATE AMINOTRANSFERASE (AST), OR TOTAL BILIRUBIN (T-BIL), AS EVIDENCED BY THE MOST RECENT CHEMISTRY PANEL RESULTSIN THE PARENT STUDY, MEETING ANY ONE OF THE FOLLOWING CRITERIA:
•A) ALT OR AST> 8 X ULN.
•B) ALT OR AST> 5 X ULN FOR MORE THAN 2 WEEKS.
•C) ALT OR AST> 3 x ULN AND (T-BIL> 2 x ULN OR INTERNATIONAL NORMALIZED RATIO [INR]> 1.5) AT THE SAME VISIT.
•D) ALT OR AST> 3 x ULN WITH THE APPEARANCE OF WORSENING FATIGUE, NAUSEA, VOMITING, RIGHT UPPER QUADRANT PAIN OR TENDERNESS, FEVER, RASH AND/OR EOSINOPHILIA (> 5%).

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