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NCT02480335: CEASESTIFF
The Clinical And Subclinical Effects on Arterial Stiffness of Bosentan in Patients With Systemic Sclerosis
Phase 4 trial testing bosentan in Scleroderma, Systemic in 20 participants. Completed in 30 July 2018.
30 July 2018
Quick facts
| Lead sponsor | University Medical Center Groningen |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 26 June 2015 |
| Primary completion | 30 July 2018 |
| Estimated completion | 30 July 2018 |
| Sites | 1 location across Netherlands |
Drugs / interventions tested
- bosentan (BOSENTAN) — full drug profile →
Conditions studied
- Scleroderma, Systemic — all drugs for Scleroderma, Systemic →
Sponsor
University Medical Center Groningen
Who can join
18 and older, any sex, with Scleroderma, Systemic. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The aim of the study is to investigate whether bosentan added to usual care improves arterial stiffness after 3 months as measured as the pulse wave velocity (PWV) of the medium and large arteries corrected for blood pressure changes in patients with systemic sclerosis (SSc) with digital ulcers (DU). Patients will be randomized into a group with usual care and bosentan (n=10) or usual care only (n=10). PWV will be assessed at baseline, 3 months and 12 months.
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 NCT02480335
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of bosentan
Trials testing the same drug.
- NCT04991207 — Effect of BIA 5-1058 400 mg on the Steady State Pharmacokinetics of Bosentan · Phase 1 · completed
- NCT01223352 — Effects of Two Dosing Regimens of Bosentan in Children With Pulmonary Arterial Hypertension · Phase 3 · completed
Other recruiting trials for Scleroderma, Systemic
Currently open trials in the same condition.
- NCT06256575 — Study of Diosmin for the Treatment of Digital Ulcers in Systemic Sclerosis · NA · recruiting
- NCT06697561 — Development and Evaluation of an Evidence-based Education Program for People With Hand Dysfunction in Scleroderma · NA · active not recruiting
- NCT05878717 — A Study of the Efficacy and Safety of Belimumab in Adults With Systemic Sclerosis Associated Interstitial Lung Disease · Phase 2, PHASE3 · recruiting
- NCT07345052 — Western Sweden Systemic Sclerosis Project · recruiting
Other University Medical Center Groningen trials
Trials by the same sponsor.
- NCT06647602 — Thyroid Hormone Replacement After Radio Iodine: Value and Efficacy · not yet recruiting
- NCT06809946 — Feasibility of Fluorescence Imaging With Bevacizumab-800CW During Bronchoscopy · Phase 2 · not yet recruiting
- NCT07527390 — CANagliflozin In DIALysis Patients · Phase 4 · not yet recruiting
- NCT07439237 — Implant-supported Maxillary Overdentures; a 15-years Evaluation · not yet recruiting
- NCT07275437 — Effectiveness and Safety of Uptitration of Guideline Directed MEdical Therapy in Heart Failure With Reduced Ejection Fra · NA · not yet recruiting
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 NCT02480335 (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 University Medical Center Groningen
- Last refreshed: 13 December 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/NCT02480335.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing