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NCT01389271: OPTION
Inhaled Iloprost in the Treatment of Patients With Pulmonary Hypertension up to 4 Years
trial testing Ventavis inhaled (Iloprost, BAYQ6256) in Pulmonary Hypertension in 118 participants. Completed in 18 June 2018.
8 March 2017
Quick facts
| Lead sponsor | Bayer |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 118 |
| Start date | 3 February 2011 |
| Primary completion | 8 March 2017 |
| Estimated completion | 18 June 2018 |
| Sites | 1 location across Turkey (Türkiye) |
Drugs / interventions tested
- Ventavis inhaled (Iloprost, BAYQ6256) — full drug profile →
Conditions studied
- Pulmonary Hypertension — all drugs for Pulmonary Hypertension →
Sponsor
Bayer — full company profile →
Who can join
18 and older, any sex, with Pulmonary Hypertension. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is an open-label, uncontrolled, prospective long-term observation of Specific Drug in the treatment of patients with pulmonary hypertension up to 4 years. 160 patients with primary (idiopathic and familial) pulmonary hypertension (PH) or pulmonary arterial hypertension (PAH) due to scleroderma with New York Heart Association (NYHA) functional class and exercise capacity, defined as class III and IV planned to enroll. Efficacy, safety and tolerability of the drug and the survival of the patients will be observed.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT01389271
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Bayer trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01389271 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Bayer
- Last refreshed: 25 April 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01389271.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing