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Clinical Trials/EUCTR2012-001134-33-DE
EUCTR2012-001134-33-DE
Active, not recruiting
Not Applicable

Randomized, Double-Blind, Placebo-Controlled Trial of Ferric Carboxymaltose Versus Placebo in Patients with Congestive Heart Failure - Iron in Congestive Heart Failure – iCHF

niversitätsklinikum Ulm0 sitesAugust 28, 2012
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DrugsFerinject 50 mg Eisen/ml

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
niversitätsklinikum Ulm
Status
Active, not recruiting
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 28, 2012
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
niversitätsklinikum Ulm

Eligibility Criteria

Inclusion Criteria

  • •\-Congestive heart failure
  • •\-at least 18 years of age
  • •\-iron deficiency
  • •\-NYHA class II or III
  • •\-LVEF \< 40%
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range 50
  • •F.1\.3 Elderly (\>\=65 years) yes

Exclusion Criteria

  • •\-Known sensitivity to any of the products to be administered during dosing
  • •\-immediate need of transfusion
  • •\-patients presenting with an active infection
  • •\-Thalassaemia
  • •\-other forms of microcytic anemia not caused by iron deficiency
  • •\- history of acquired iron overload
  • •\-need for revascularization
  • •\-STEMI or Non\-STEMI during the past 4 months
  • •\-women who are pregnant or of childbearing age and not using medically acceptable effective contraception.

Outcomes

Primary Outcomes

Not specified

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