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NCT00752596
Compassionate Use Study to Assess the Long Term Safety of 125 mg Per Day of Oral Azimilide Dihydrochloride in One Patient Following Termination of the SHIELD Open-label Study 2001060
Phase 2 trial testing Azimilide 2HCl in Congestive Heart Failure in 1 participant. Completed in 1 July 2006.
1 July 2006
Quick facts
| Lead sponsor | Forest Laboratories |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 1 |
| Start date | 1 September 2005 |
| Primary completion | 1 July 2006 |
| Estimated completion | 1 July 2006 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Azimilide 2HCl — full drug profile →
Conditions studied
- Congestive Heart Failure — all drugs for Congestive Heart Failure →
Sponsor
Forest Laboratories — full company profile →
Who can join
Eligibility, male only, with Congestive Heart Failure. 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.
- There was no outcome measure in this compassionate use
Sponsor's own description
This is an open-label, long term compassionate use study of 125 mg per day of azimilide 2HCl in a patient who completed two other protocols (2000098 and 2001060.
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 NCT00752596
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Congestive Heart Failure
Currently open trials in the same condition.
- NCT07008365 — The Role of intraABDOminal Pressure and Point Of Care UltraSound to Guide Decongestive Therapy in Heart Failure · Phase 3 · recruiting
- NCT06526884 — Quasi-Randomized Evaluation of the UCLA Next Day Clinic (NDC) · NA · active not recruiting
- NCT06495892 — PVP-Guided Decongestive Therapy in HF 2 · Phase 4 · recruiting
- NCT06374277 — Pharmacy-led Transitions of Care Intervention to Improve Medication Adherence · NA · recruiting
- NCT05971225 — Verifying Remote Monitoring Effect on Net Cardiovascular Outcome; RemoteVerify (RêVe) · NA · 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 NCT00752596 (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/NCT00752596.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing