Full results & analysis
Available in the Gosset platform where reported.
Trial intelligence / Profile preview
SPHERIC-1 Open Extension
2011-002018-35Phase 3
Key facts
- Status
- Completed
- Start
- Oct 2012
- Countries
- 1
- Sponsor
- Associazione Italiana Pneumologi Ospedalieri
- Modality
- Small Molecules
- Drugs
- sildenafil
- Conditions
- pulmonary hypertension (PH)chronic obstructive pulmonary disease (COPD)
01
Overview
Phase 3, open-label, single-arm trial of sildenafil in pulmonary hypertension (PH) and chronic obstructive pulmonary disease (COPD), sponsored by Associazione Italiana Pneumologi Ospedalieri. Primary endpoint: Adverse events during sildenafil treatment. Started Oct 2012; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Open-label sildenafil
Single-group extension arm receiving sildenafil citrate after completion of SPHERIC-1
03
Who it enrols
Adults aged 18 to 80 years who had been enrolled in and completed SPHERIC-1, with stable COPD on optimal pharmacological treatment, and receiving chronic oxygen therapy if hypoxic, were eligible. Required blood gas criteria included resting PaO2 of at least 60 mmHg and PaCO2 of 55 mmHg or less.
04
Endpoints
Primary
Adverse events during sildenafil treatment
Beyond the preview
Go deeper on 2011-002018-35.
Full results, competitive context and analysis are in the Gosset platform.
Competitive context
Available in the Gosset platform where reported.
Bring the full picture into focus.
See how Gosset can support your research on 2011-002018-35.