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NCT01995734: ACCESS
An Open-label, Multi-center, Expanded Treatment Protocol of Pasireotide LAR in Patients With Acromegaly
trial testing Pasireotide long acting release formulation in Acromegaly. Approved for marketing.
Quick facts
| Lead sponsor | Novartis Pharmaceuticals |
|---|---|
| Status | APPROVED FOR MARKETING |
| Study type | EXPANDED_ACCESS |
| Sites | 37 locations across United States |
Drugs / interventions tested
- Pasireotide long acting release formulation — full drug profile →
Conditions studied
- Acromegaly — all drugs for Acromegaly →
Sponsor
Novartis Pharmaceuticals — full company profile →
Who can join
18 and older, any sex, with Acromegaly. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The present study is planned as an expanded treatment protocol to provide acromegalic patients for whom medical therapy is appropriate access to pasireotide LAR while regulatory approval for pasireotide is sought.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Safety and tolerability of pasireotide long-acting release in acromegaly-results from the acromegaly, open-label, multicenter, safety monitoring program for treating patients who have a need to receive medical therapy (ACCESS) study.
Fleseriu M, Rusch E, Geer EB, ACCESS Study Investigators. · · 2017 · cited 40× · PMID 27896545 · DOI 10.1007/s12020-016-1182-4 -
Analgesic effect of long-acting somatostatin receptor agonist pasireotide in a patient with acromegaly and intractable headaches.
Lovato CM, Kapsner PL. · · 2018 · cited 10× · PMID 29925553 · DOI 10.1136/bcr-2017-219686 -
Patients with Acromegaly Presenting with Colon Cancer: A Case Series.
Gordon MB, Nakhle S, Ludlam WH. · · 2016 · cited 6× · PMID 28025627 · DOI 10.1155/2016/5156295 -
Successful debulking of plurihormonal pituitary macroadenoma with long-acting pasireotide and dopamine agonist combination therapy.
Jerkins TW, Jerkins RK, Franklin R. · · 2019 · cited 1× · PMID 30899469 · DOI 10.1002/ccr3.1961
Verify or expand the search:
- PubMed search for NCT01995734
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Acromegaly
Currently open trials in the same condition.
- NCT07037420 — ALXN2420 Versus Placebo in Combination With Somatostatin Analogs in Participants With Acromegaly · Phase 2 · recruiting
- NCT05401084 — Diet in the Management of Acromegaly · NA · recruiting
- NCT05131100 — Korean Regulatory Post Marketing Surveillance for Somavert · recruiting
- NCT05964712 — Effects of Therapies in the Acromegaly Disease: Acral Morpho-functional Study · recruiting
- NCT03158090 — The Longitudinal Approach to Acromegaly: A Pattern of Treatment and Comparative Effectiveness Research · recruiting
Other Novartis Pharmaceuticals trials
Trials by the same sponsor.
- NCT07498335 — Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary · Phase 3 · not yet recruiting
- NCT07489573 — Study of Efficacy and Safety of Secukinumab in Chinese Adult Patients With Moderate to Severe Hidradenitis Suppurativa · Phase 4 · not yet recruiting
- NCT07484269 — PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan · not yet recruiting
- NCT07416162 — A Study of Iptacopan in Korean Patients With Paroxysmal Nocturnal Hemoglobinuria or C3 Glomerulopathy · not yet recruiting
- NCT07387926 — Safety and Efficacy of Asciminib in Pediatrics and Young Adults With Relapse/Refractory (r/r) Philadelphia Positive (Ph+ · Phase 1, PHASE2 · 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 NCT01995734 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
- Last refreshed: 29 December 2015
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/NCT01995734.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing