Conditions: Autosomal Dominant Polycystic Kidney Disease
Keywords: Kidney Disease Polycystic Kidney Disease Autosomal Dominant Polycystic Kidney Disease PKD ADPKD
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 178
Healthy volunteers: no

Brief summary:
The purpose of this study is to compare the short-term effects of two tolvaptan formulations in patients with ADPKD.

Detailed description:

Arms:
arm 1: Tolvaptan MR 50 mg capsule and 2 placebo IR tablets ( 8 AM) and 1 placebo IR tablet (4 PM) daily. arm 2: Tolvaptan MR 80 mg capsule and 2 placebo IR tablets (8 AM) and 1 placebo IR tablet (4 PM) daily. arm 3: Two tolvaptan IR 30-mg tablets and 1 placebo MR capsule (8 AM) and 1 tolvaptan IR 30-mg tablet (4 PM) daily. arm 4: Placebo MR capsule and 2 placebo IR tablets (8 AM) and 1 placebo IR tablet (4 PM) daily.

Interventions: intervention 1: Tolvaptan MR intervention 2: Tolvaptan IR intervention 3: Placebo
Intervention descriptions: intervention 1: 50/80 mg capsules intervention 2: 60/30 mg capsules intervention 3: tablet

Protocol document: