Printed from Voxsanity (voxsanity.com.au) — NCT00358215 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
This trial is complete. It is no longer accepting participants. Results may be available on ClinicalTrials.gov.
Trial results
AI generated results summary.
Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source.
How we use AI
According to the results reported on ClinicalTrials.gov, this trial enrolled 2,278 people with heart failure — 1,142 in the placebo group and 1,136 in the darbepoetin alfa (a medication used to stimulate red blood cell production) group. The trial was measuring whether darbepoetin alfa made a difference to how long it took for participants to either die from any cause or be admitted to hospital for worsening heart failure. Roughly 1,100 people in each group did not complete the study, for various reasons.
The reported data shows that the primary outcome — the estimated midpoint time (meaning the point by which half of participants had experienced the event) before either dying or being hospitalised for worsening heart failure — was 1,260 days in the placebo group and 1,184 days in the darbepoetin alfa group. For death from any cause alone, the reported figures were 1,637 days for placebo and 1,629 days for darbepoetin alfa. For the combined measure of cardiovascular death or first hospitalisation for worsening heart failure, the reported figures were 1,414 days for placebo and 1,395 days for darbepoetin alfa. The trial also used a heart failure quality-of-life questionnaire (scored 0–100, where higher scores mean better wellbeing). The reported average improvement from the start of the study to six months was 4.48 points for placebo and 6.68 points for darbepoetin alfa on the overall summary score, and 3.91 versus 6.20 points on the symptom frequency score.
These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 3 Cardiomyopathy Trial, Completed
NCT00358215
CompletedPhase 3🇦🇺 Australian site
Who may be able to join
AI generated eligibility summary.
Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source.
How we use AI
Who might be able to join this trial:
You have been living with heart failure for at least 3 months, and your symptoms are classified as moderate to severe (NYHA class II, III, or IV — confirm with trial site if unsure of your class)
Your red blood cell levels (hemoglobin) are mildly low, falling between 9.0 and 12.0 g/dL (your doctor can check this with a blood test)
Your heart's pumping strength is reduced, with the heart pumping out 40% or less of blood with each beat (known as ejection fraction — your doctor can confirm this)
Who may not be able to join:
Your iron levels in the blood are very low, specifically a measure called "transferrin saturation" is below 15% (your doctor can check this with a blood test)
Your blood pressure is higher than 160/100 mmHg
Your heart failure is mainly caused by problems with your heart valves, or you have significant valve disease that may require surgery within the next 12 months
You have received a major organ transplant (such as a kidney, liver, or heart) or you are currently on dialysis or another form of kidney replacement treatment
Your kidney function is significantly reduced, shown by a blood marker called creatinine being above 3.0 mg/dL (your doctor can check this)
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.
Contact this trial
Principal Investigator: MD, Amgen
Australian sites
Research Site, Camperdown, New South Wales
Research Site, Coffs Harbour, New South Wales
Research Site, Concord, New South Wales
Research Site, Gosford, New South Wales
Research Site, New Lambton Heights, New South Wales
Research Site, Randwick, New South Wales
Research Site, Chermside, Queensland
Research Site, Kippa-Ring, Queensland
Research Site, Woolloongabba, Queensland
Research Site, Bedford Park, South Australia
Research Site, Geelong, Victoria
Research Site, Heidelberg, Victoria
Research Site, Parkville, Victoria
Research Site, Prahran, Victoria
Research Site, Nedlands, Western Australia
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Voxsanity
Clinical trials and treatments, explained plainly · voxsanity.com.au
Date:
To: My Doctor
Re: Clinical trial enquiry
I found the following past clinical trial relevant to my condition, and wanted to raise it with you. It is no longer recruiting, but I wanted to ask whether similar active trials exist, or whether its results are relevant to my care:
Trial: NCT00358215
Sponsor: Amgen
Phase: Phase 3
Status: Completed
Condition: Cardiomyopathy
More information: https://clinicaltrials.gov/study/NCT00358215
Eligibility summary (AI generated)
Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.
Who might be able to join this trial:
You have been living with heart failure for at least 3 months, and your symptoms are classified as moderate to severe (NYHA class II, III, or IV — confirm with trial site if unsure of your class)
Your red blood cell levels (hemoglobin) are mildly low, falling between 9.0 and 12.0 g/dL (your doctor can check this with a blood test)
Your heart's pumping strength is reduced, with the heart pumping out 40% or less of blood with each beat (known as ejection fraction — your doctor can confirm this)
Who may not be able to join:
Your iron levels in the blood are very low, specifically a measure called "transferrin saturation" is below 15% (your doctor can check this with a blood test)
Your blood pressure is higher than 160/100 mmHg
Your heart failure is mainly caused by problems with your heart valves, or you have significant valve disease that may require surgery within the next 12 months
You have received a major organ transplant (such as a kidney, liver, or heart) or you are currently on dialysis or another form of kidney replacement treatment
Your kidney function is significantly reduced, shown by a blood marker called creatinine being above 3.0 mg/dL (your doctor can check this)
Important: Always verify eligibility with the trial site directly before applying.
Access in Australia: A treatment being studied in a clinical trial is generally not yet listed on the PBS. Where a medicine is not approved or not available through a trial, the TGA Special Access Scheme may allow a doctor to access unapproved therapeutic goods for individual patients. See voxsanity.com.au/sas-navigator/ for a plain English explainer.
This information was sourced from ClinicalTrials.gov via Voxsanity (data last synced 27 July 2026). It is not medical advice. Please verify the trial's current status directly with the trial site before acting.
🇦🇷 Argentina
🇦🇺 Australia
🇦🇹 Austria
🇧🇪 Belgium
🇧🇷 Brazil
🇧🇬 Bulgaria
🇨🇦 Canada
🇨🇱 Chile
🇨🇿 Czechia
🇩🇰 Denmark
🇪🇪 Estonia
🇫🇮 Finland
🇫🇷 France
🇩🇪 Germany
Hong Kong
🇭🇺 Hungary
🇮🇳 India
🇮🇱 Israel
🇮🇹 Italy
🇱🇻 Latvia
🇱🇹 Lithuania
🇲🇽 Mexico
🇳🇱 Netherlands
🇳🇴 Norway
🇵🇱 Poland
🇵🇹 Portugal
Puerto Rico
🇷🇴 Romania
🇷🇺 Russia
🇸🇰 Slovakia
🇿🇦 South Africa
🇪🇸 Spain
🇸🇪 Sweden
🇨🇭 Switzerland
🇬🇧 United Kingdom
🇺🇸 United States
15 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Time to All Cause Death or First Hospitalization for Worsening Heart Failure
Can't join this trial?
Expanded access pathways
If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.
Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.
Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.