Congestive Heart FailurePhase 2NCT00752596
Compassionate Use Study of 125 mg Per Day of Azimilide Dihydrochloride in One Patient
A Phase 2 study testing Azimilide 2HCl in people with Congestive Heart Failure, run by Forest Laboratories at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Congestive Heart Failure
- What is being tested?
- Azimilide 2HCl
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to Jul 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- No inclusion criteria as the patient to be included is this compassionate use protocol is currently receiving azimilide therapy
Who cannot join
- Currently taking Class I or other Class III antiarrhythmic drug or other drugs that may prolong QT interval.
- Is unwilling or unable to give or understand informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
- Conditions
- Congestive Heart Failure
- Being tested
- Azimilide 2HCl
- Keywords
- patients, with ICD
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Azimilide 2HClDrug
One tablet of 125 mg/day azimilide 2HCl, taken until the study is terminated
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 1 tablet of 125 mg/day of azimilide 2HCl, oral Receives: Drug: Azimilide 2HCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
There was no outcome measure in this compassionate use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2008 (estimated)
- Study startSep 2005
- Primary completionJul 2006
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Forest Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Stephen R Marcello, MD, Study director, Procter and Gamble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00752596
- Sponsor's protocol ID
- 2005076
- Status last verified
- Jan 2017
- First submitted
- 11 Sep 2008
- Last updated
- 1 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00752596
- Acronym / sponsor ID
- 2005076
- Conditions
- Congestive Heart Failure
- Keywords
- patients, with ICD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Forest LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- Sep 2005
- Primary completion
- Jul 2006 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 15 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Azimilide 2HCl1 tablet of 125 mg/day of azimilide 2HCl, oral |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- No inclusion criteria as the patient to be included is this compassionate use protocol is currently receiving azimilide therapy
Key exclusion criteria (2 listed)
- Currently taking Class I or other Class III antiarrhythmic drug or other drugs that may prolong QT interval.
- Is unwilling or unable to give or understand informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Azimilide 2HClOne tablet of 125 mg/day azimilide 2HCl, taken until the study is terminated | Drug | 1 |
Primary outcome
There was no outcome measure in this compassionate use
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen R Marcello, MD study director
Procter and Gamble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Azimilide 2HCl in people with Congestive Heart Failure, run by Forest Laboratories at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
There was no outcome measure in this compassionate use. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2017.