WHO ICTRP trial

A 16-Week International, Multicenter, Double-Blind, Randomized, Placebo…

EUCTR2006-000800-17-IE · EU Clinical Trials Register · Not Recruiting

Key facts

Trial ID EUCTR2006-000800-17-IE
Public title A 16-Week International, Multicenter, Double-Blind, Randomized, Placebo Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination with an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C
Scientific title A 16-Week International, Multicenter, Double-Blind, Randomized, Placebo Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination with an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor in Subjects with Pulmonary Arterial…
Primary sponsor United Therapeutics Corporation
Registry EU Clinical Trials Register
Recruitment status Not Recruiting
Study type Interventional clinical trial of medicinal product
Countries Germany;United Kingdom;Netherlands;Belgium;France;Spain;Ireland;Italy;Austria
Conditions Idiopathic or Familial pulmonary arterial hypertension (PAH), including PAH associated with: 1) Appetite suppressant use, or 2) Repaired congenital systemic-to-pulmonary shunts (repaired = 5 years), or 3) Collagen Vascular Disease (CVD), or…
Interventions Product Name: Treprostinil Diethanolamine Product Code: UT-15C SR Pharmaceutical Form: Coated tablet INN or Proposed INN: Treprostinil diethanolamine Current Sponsor code: UT-15C SR Concentration unit: mg milligram(s) Concentration type…
Registration date Nov 13, 2006
Target size 300
Secondary IDs TDE-PH-301
Registry page clinicaltrialsregister.eu

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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date:

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