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血液透析(血液濾過および血液透析濾過を含む)で管理されている慢性腎臓病(CKD)に伴う症候性むずむず脚症候群(RLS)と診断された患者におけるロピニロールIR(即放性)錠の臨床評価

基本情報

NCT ID
NCT00996944
ステータス
中止
試験のフェーズ
第2相
試験タイプ
介入
目標被験者数
34
治験依頼者名
GlaxoSmithKline

概要

This is a multicenter, placebo controlled, parallel group, double-blind, randomized comparison study to evaluate the efficacy and safety of ropinirole IR tablets orally administered for 12 weeks in patients with symptomatic restless legs syndrome associated with Chronic kidney disease (CKD) managed with haemodialysis (including haemofiltration and haemodiafiltration) (hereinafter referred to as "uRLS"), to evaluate the efficacy and safety of long-term administration of ropinirole IR tablets, and assess the effect on the steady state pharmacokinetics in the long-term administration period of ropinirole IR tablets.

対象疾患

Restless Legs Syndrome

介入

Ropinirole immediate release (IR)(DRUG)
Placebo(DRUG)

依頼者(Sponsor)