6 results
The primary efficacy variable is the change in PV from baseline as assessed by 3 D ultrasonography after 78 weeks of double-blind treatment with OM 20-40 mg daily compared to ATE 50-100 mg daily.Secondary efficacy variables:Change from baseline PV…
To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by SAR236553 in comparison withezetimibe after 24 weeks of treatment in patients with hypercholesterolemia
Primary: long-term safety and efficacy of SAR236553 in high risk patients with an insufficiently controlled hypercholestolemia despite treatment with existing lipid modifying drugs.Secondary objectives: effect on individual lipids, development of…
Determinination of the added effects of dietary sodium restriction or diuretic use to antihypertensive and antialbuminuric therapy.
1. Overall survival (primary efficacy endpoint)2a. Efficacy: progression-free survival (PFS), overall response rate (ORR = CR + PR), and a clincal benefit rate (CBR) will be evaluated as CR + PR + SD for at least 3 months.2b. Safety: adverse events…
To demonstrate whether hydrochlorothiazide or metformin can diminish aquaresis in patients with ADPKD who are treated with tolvaptan as measured by 24-hour urine volume.