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NCT00751738
A Multi-center, Open-label, Follow-up Study to Assess the Long-term Safety of 125 mg Per Day of Oral Azimilide Dihydrochloride in Patients With an Implantable Cardioverter Defibrillator
Phase 3 trial testing azimilide dihydrochloride in Arrhythmias in 330 participants. Completed in 1 October 2005.
1 October 2005
Quick facts
| Lead sponsor | Forest Laboratories |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 330 |
| Start date | 1 October 2002 |
| Primary completion | 1 October 2005 |
| Estimated completion | 1 October 2005 |
| Sites | 86 locations across United States, Belgium, Canada, France, Germany, Poland, Spain |
Drugs / interventions tested
- azimilide dihydrochloride — full drug profile →
Conditions studied
- Arrhythmias — all drugs for Arrhythmias →
Sponsor
Forest Laboratories — full company profile →
Who can join
18 and older, any sex, with Arrhythmias. 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.
-
safety of azimilide in this patient population
Time frame: 1 year
Sponsor's own description
This is an open-label, multi-center, long-term, (open-ended) safety study with 125 mg per day of azimilide in patients who completed protocol 2000098.
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 NCT00751738
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Arrhythmias
Currently open trials in the same condition.
- NCT06039176 — Human/Machine Interface: What the HeartMate 3 ® Device Tells Us About the Future · recruiting
- NCT07336225 — CMR-Based Prognostic Study in Patients With Cardiac Implantable Electronic Devices · recruiting
Other Forest Laboratories trials
Trials by the same sponsor.
- NCT02788617 — Evaluation of the Efficacy of Diafert in Predicting Embryos' Potential to Develop to the Blastocyst Stage · completed
- NCT02732327 — Comparative Study of Ceftazidime-Avibactam Versus Standard of Care as Therapy in Febrile Neutropenic Adults With Cancer · Phase 2 · terminated
- NCT02670538 — Study of the Efficacy of a Fixed-dose Regimen of Cariprazine Compared to Placebo for Treatment of the Depressive Episode · Phase 3 · completed
- NCT02670551 — Study on the Efficacy, Safety, and Tolerability of Cariprazine Relative to Placebo in Participants With Bipolar I Depres · Phase 3 · completed
- NCT02559570 — A Safety and Efficacy Study of a Range of Linaclotide Doses Administered Orally to Children Ages 6-17 Years Who Fulfill · Phase 2 · completed
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 NCT00751738 (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 Forest Laboratories
- Last refreshed: 31 January 2017
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/NCT00751738.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing