WHO ICTRP trial
A Study to Evaluate the Efficacy, Safety, and Tolerability of Sildenafil Added…
EUCTR2015-005131-40-ES · EU Clinical Trials Register · Authorised
Key facts
| Trial ID | EUCTR2015-005131-40-ES |
|---|---|
| Public title | A Study to Evaluate the Efficacy, Safety, and Tolerability of Sildenafil Added to Pirfenidone in Patients with Advanced Idiopathic Pulmonary Fibrosis and Intermediate or High Probability of Pulmonary Hypertension due to the lung disease. |
| Scientific title | A PHASE IIb, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF SILDENAFIL ADDED TO PIRFENIDONE IN PATIENTS WITH ADVANCED IDIOPATHIC PULMONARY FIBROSIS AND INTERMEDIATE OR HIGH PROBABILITY OF GROUP 3 PULMONARY HYPERTENSION. |
| Primary sponsor | F. Hoffmann-La Roche Ltd |
| Registry | EU Clinical Trials Register |
| Recruitment status | Authorised |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no |
| Countries | United Arab Emirates;Greece;Spain;Turkey;Israel;Italy;Egypt;Czech Republic;Hungary;Canada;Belgium;South Africa;Germany;Netherlands |
| Conditions | "Pulmonary Hypertension in patients with Idiopathic pulmonary fibrosis (IPF) MedDRA version: 19.0 Level: PT Classification code 10021240 Term: Idiopathic pulmonary fibrosis System Organ Class: 10038738 - Respiratory, thoracic and… |
| Interventions | Trade Name: Esbriet Product Name: Esbriet Product Code: RO0220912 Pharmaceutical Form: Capsule, hard INN or Proposed INN: PIRFENIDONE CAS Number: 53179-13-8 Current Sponsor code: RO0220912 Concentration unit: mg milligram(s) Concentration… |
| Registration date | Sep 9, 2016 |
| Target size | 176 |
| Secondary IDs | MA29957 |
| Registry page | clinicaltrialsregister.eu |
At a glance
- No Results available
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About WHO ICTRP trial registrations
The WHO ICTRP combines trial registrations from primary registries worldwide into a single searchable index. Contact and ethics-committee details are not shown here.
Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: