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NCT01137565
A Randomized, Double-Blind, Placebo-Controlled, Single Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of AMG 853 in Adolescent (≥ 12 to <18 Years) and Adult Subjects With Intermittent or Mild to Moderate Persistent Asthma
Phase 1 trial testing AMG 853 in Asthma in 23 participants. Completed in 1 January 2011.
1 January 2011
Quick facts
| Lead sponsor | Amgen |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | basic science |
| Enrollment | 23 |
| Start date | 1 June 2010 |
| Primary completion | 1 January 2011 |
| Estimated completion | 1 January 2011 |
Drugs / interventions tested
- AMG 853 — full drug profile →
- Placebo
Conditions studied
- Asthma — all drugs for Asthma →
Sponsor
Amgen — full company profile →
Who can join
Adults 12 to 50, any sex, with Asthma. 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.
-
Evaluation of treatment-emergent adverse events, safety and laboratory assessments in adolescent subjects with intermittent or mild to moderate asthma as a measure of safety and tolerability
Time frame: Throughout the study duration
Sponsor's own description
The purpose of this study is to study the safety and tolerability in adolescent and adult subjects with intermittent or mild to moderate persistent asthma.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Intermittent versus daily inhaled corticosteroids for persistent asthma in children and adults.
Chauhan BF, Chartrand C, Ducharme FM. · · 2013 · cited 36× · PMID 23450606 · DOI 10.1002/14651858.cd009611.pub3
Verify or expand the search:
- PubMed search for NCT01137565
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Amgen 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 NCT01137565 (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 Amgen
- Last refreshed: 3 March 2014
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/NCT01137565.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing