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NCT03139084: BOTA-PAH
Efficacy and Safety of Upfront Combination of ΒΟsentan and ΤΑdalafil in Pulmonary Arterial Hypertension
trial in Pulmonary Hypertension. Withdrawn.
1 December 2019
Quick facts
| Lead sponsor | Elpen Pharmaceutical Co. Inc. |
|---|---|
| Status | Withdrawn |
| Study type | OBSERVATIONAL |
| Start date | 1 December 2017 |
| Primary completion | 1 December 2019 |
| Estimated completion | 1 December 2019 |
Conditions studied
- Pulmonary Hypertension — all drugs for Pulmonary Hypertension →
Sponsor
Elpen Pharmaceutical Co. Inc. — full company profile →
Who can join
Adults 18 to 75, any sex, with Pulmonary Hypertension. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The development of disease-targeted drugs for the treatment of pulmonary arterial hypertension (PAH) has significantly improved within the last years. Combining drug products with different mechanisms of action such as Endothelin-Receptor-Antagonists (ERAs) and Phosphodiesterase-Type-5-inhibitors (PDE-5-Inhibitors) has become increasingly important for the treatment of PAH. Recently, the results of the AMBITION study reported that an upfront combination treatment of ambrisentan and tadalafil immediately after diagnosis leads to a delayed disease progression. On the other hand, the sequential combination of bosentan and sildenafil did not show a similar positive clinical effect and this was attributed to a negative clinically relevant pharmacodynamic drug-drug interaction. Although, recent guidelines have extrapolated that initial upfront combination treatment follows a class effect in terms of efficacy and safety, there is an imperative need to support this notion with other combinations of ERAs and PDE-5-Inhibitors.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03139084
- Europe PMC full search
- ASCO Meeting Library
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- bioRxiv preprints
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Other Elpen Pharmaceutical Co. Inc. 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 NCT03139084 (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 Elpen Pharmaceutical Co. Inc.
- Last refreshed: 26 January 2018
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/NCT03139084.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing