A Phase 2, 36 Week, Open-Label, Uncontrolled Safety Follow-Up Study Assessing SCH 420814 5 mg BID - N/A

Schering Plough Research Institute0 个研究点目标入组 200 人开始时间: 2007年9月11日最近更新: 2022年4月4日

研究概览

暂无简介。

•Subjects must have participated in OR COMPLETED the parent Study P04501.
•Subjects must be =30 years of age, of either sex and of any race, with a diagnosis of moderate to severe idiopathic Parkinson’s disease for at least 5 years.
•Subjects must have been on a regimen of L-Dopa and a dopamine agonist.
•Subjects must have a systolic BP = 160 mm Hg and a diastolic BP = 90 mm Hg.
•Women of childbearing potential must have had a negative serum pregnancy test at Visit 1. If subject is postmenopausal (not surgically induced), she must be postmenopausal by history for at least 2 years before study entry. If not, proper birth control must be used.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Subjects who discontinued from the parent Study P04501 because they experienced a serious adverse event (SAE).
•Subjects who discontinued from the parent Study P04501 because of elevated LFT test results.
•Subjects with values of greater than the upper limit of normal (ULN) at Visit 1 for any of the following LFTs: alanine aminotransferase (ALT) (SGPT), aspartate aminotransferase (AST) (SGOT), gamma glutamyl transferase (GGT), alkaline phosphatase (ALK-P), and total bilirubin (T-BIL).
•Average daily consumption of more than two 4-oz (120 mL) glasses of wine or their equivalent.
•Elevated BP (systolic BP =160 mm Hg; OR diastolic BP = 90 mm Hg).
•Subjects who have received any prohibited treatment including potentially hepatotoxic drugs more recently than the indicated washout period prior to Visit 1.
•Women who are breast-feeding or who are considering breast-feeding.

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