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NCT01424241
Metabolic, Cardiovascular and Body Composition Effects of Sandostatin LAR® Therapy of Acromegaly, Effect of Reduction of Serum Insulin-like Growth Factor 1 (IGF-1) Levels Into a New Normative Range
Phase 4 trial testing Sandostatin LAR in Acromegaly in 21 participants. Completed in 1 January 2014.
1 March 2013
Quick facts
| Lead sponsor | Columbia University |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 21 |
| Start date | 1 October 2006 |
| Primary completion | 1 March 2013 |
| Estimated completion | 1 January 2014 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Sandostatin LAR — full drug profile →
Conditions studied
- Acromegaly — all drugs for Acromegaly →
Sponsor
Columbia University
Who can join
18 and older, any sex, with Acromegaly. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
IGF-1 Level on Sandostatin LAR
Time frame: Up to 9 months
Mean IGF-1 level on treatment with Sandostatin LAR in whole population and responders (normal IGF1) and non responders(elevated IGF-1)
Sponsor's own description
This study aims primarily to determine the effect Insulin-like Growth Factor 1 (IGF-1) normalization into current IGF-I normal ranges with Sandostatin LAR® therapy on biochemical metabolic, cardiovascular and body composition parameters in patients with active acromegaly.
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 NCT01424241
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Sandostatin LAR
Trials testing the same drug.
- NCT05364944 — A Study to Assess the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Debio 4126 in Participants With Ac · Phase 1 · terminated
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 Columbia University trials
Trials by the same sponsor.
- NCT06558422 — Human Models of Selective Insulin Resistance: Pancreatic Clamp · Phase 1 · not yet recruiting
- NCT07264582 — HIV/STI/HCV Testing and Overdose Prevention Among Survivors of Sex Trafficking · NA · not yet recruiting
- NCT05992415 — Know Your Pressures NYC · NA · not yet recruiting
- NCT05645211 — The AgRP and GH/IGF-1 Axis in Children · not yet recruiting
- NCT07403604 — Effect of Insulin Lowering on Lipogenesis · Phase 1 · 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 NCT01424241 (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 Columbia University
- Last refreshed: 22 July 2024
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/NCT01424241.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing