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A double blind, placebo controlled study to assess the safety and efficacy of PCD-04 as a protective agent against anthracycline-induced cardiotoxicity.


- candidate number1413
- NTR NumberNTR236
- ISRCTNISRCTN56637853
- Date ISRCTN created20-dec-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR6-sep-2005
- Secondary IDsN/A 
- Public TitleA double blind, placebo controlled study to assess the safety and efficacy of PCD-04 as a protective agent against anthracycline-induced cardiotoxicity.
- Scientific TitleA double blind, placebo controlled study to assess the safety and efficacy of PCD-04 as a protective agent against anthracycline-induced cardiotoxicity.
- ACRONYMPROTACMI
- hypothesisSubjects in the PCD-04 arm will show less anthracyclin-induced cardiotoxicty then subjects in the placebo arm.
- Healt Condition(s) or Problem(s) studiedBreast cancer
- Inclusion criteria1. Female;
2. Willing and able to give written informed consent;
3. Between 20 75 years of age;
4. Scheduled for the current clinical routine protocol for adjuvant chemotherapy for carcinoma of the breast consisting of doxorubicin / cyclophosphamide cycles.
- Exclusion criteria1. Patients with indication of distant metastases of breast carcinoma;
2. Inability to obtain a good quality echocardiogram before study drug administration;
3. Patients who are unable to remain in supine condition for more than 1 hr;
4. Patients with (a history of) malignant disease other than carcinoma of the breast;
5. Patients with hepatic disorders evidenced by elevated transamines above 3 times the upper limit of normal;
6. Patients with a renal disorder requiring renal replacement therapy;
7. Patients with a life expectancy of less than 1 year for whatever clinical condition.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 16-sep-2003
- planned closingdate1-dec-2005
- Target number of participants72
- InterventionsThe patients are either randomised in the PCD-04 group or in the placebo group.
- Primary outcomeAssessment of safety:
this include evaluation of general safety (Blood pressure, heartrate, monitoring of the patient during infusion, laboratory tests, urinalysis).


Pharmacokinetics:
PSD-04 plasma concentrations during study days.


Pharmacodynamics (primary):
Echocardiography: Left ventricular diastolic function parameters and ejection fraction.
- Secondary outcomePharmacodynamics (secondary):
1. Biochemical markers for myocardial damage;
2. ECG parameters.
- TimepointsN/A
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESMD. F.J.F. Broeyer
- CONTACT for SCIENTIFIC QUERIESMD. J. Burggraaf
- Sponsor/Initiator LTT Bio-Pharma Co.
- Funding
(Source(s) of Monetary or Material Support)
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD7-sep-2005 - 17-sep-2008


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