NCT00035490 is a Phase 3 clinical trial of Azimilide Dihydrochloride in Arrhythmia, sponsored by Forest Laboratories.

Who is sponsoring NCT00035490?

NCT00035490 is sponsored by Forest Laboratories.

What drugs are being tested in NCT00035490?

Interventions in NCT00035490: Azimilide Dihydrochloride, placebo, Azimilide Dihydrochloride.

What condition does NCT00035490 study?

NCT00035490 studies Arrhythmia.

Is NCT00035490 still recruiting?

NCT00035490 is currently completed. Last updated 30 September 2011.

Last reviewed 2011-09-30 · How we verify

NCT00035490

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Efficacy and Safety Evaluation of Azimilide Dihydrochloride in Patients With Implantable Cardioverter Defibrillators

Completed Phase 3 Last updated 30 September 2011

What this trial tests

Phase 3 trial testing Azimilide Dihydrochloride in Arrhythmia in 633 participants. Completed in 1 April 2004.

Timeline

1 September 2001

Primary endpoint
1 April 2004

1 April 2004

Quick facts

Lead sponsor	Forest Laboratories
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	633
Start date	1 September 2001
Primary completion	1 April 2004
Estimated completion	1 April 2004
Sites	142 locations across United States, Belgium, Canada, France, Germany, Italy, Netherlands, Poland

Drugs / interventions tested

Azimilide Dihydrochloride — full drug profile →
placebo
Azimilide Dihydrochloride — full drug profile →

Conditions studied

Arrhythmia — all drugs for Arrhythmia →

Sponsor

Forest Laboratories — full company profile →

Who can join

18 and older, any sex, with Arrhythmia. 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.

Reducing the recurrence of all-cause shocks plus symptomatic ATP
Time frame: one year

Sponsor's own description

Implantable cardioverter defibrillators (ICDs) have been developed to treat ventricular tachycardia or fibrillation (abnormal heart rhythms) by electrical shock or by pacing the heart. ICD therapy is established as highly effective for stopping life-threatening arrhythmias, but it does not preclude the use of anti-arrhythmic drugs for prevention and to decrease the frequency of ICD shocks. The safety and effectiveness of oral azimilide dihydrochloride in reducing the frequency of ICD shocks has been investigated previously in a placebo-controlled study in patients with ICDs. These results need to be confirmed in this larger double-blind, placebo-controlled study with approximately 600 patients.

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:

Other recruiting trials for Arrhythmia

Currently open trials in the same condition.

NCT06989580 — BIO|CONCEPT.BIOMONITOR-HF Collect Clinical Data From Heart Failure Patients Using BIOMONITOR Devices With a Study Specif · NA · recruiting
NCT07096973 — Cardiac REhabilitation COhort at the Medicine Campus DaVos to invEstigate Recovery · recruiting
NCT06808204 — Quality of Life Before and After Transcatheter Ablation in Children With Arrythmias · NA · recruiting
NCT06984731 — The Safety and Efficacy of Radiofrequency Ablation After Left Atrial Appendage Occlusion. · recruiting
NCT06954103 — Mechanisms And Prognosis of Stroke-Heart Syndrome · 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)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00035490 (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: 30 September 2011

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/NCT00035490.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing