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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00982007
Other study ID # 1VIT09031
Secondary ID
Status Completed
Phase Phase 3
First received September 21, 2009
Last updated January 22, 2018
Start date September 2009
Est. completion date August 2011

Study information

Verified date January 2018
Source Luitpold Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The main objective of this study is to demonstrate the efficacy and safety of an investigational intravenous (IV) iron, ferric carboxymaltose (FCM), compared to oral iron in subjects who have iron deficiency anemia (IDA) and have shown an unsatisfactory response to oral iron.


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Study Design


Intervention

Drug:
Ferric Carboxymaltose (FCM)
A total maximum cumulative dose of 1500 mg administered on Days 0 and 7.
Ferrous Sulfate Tablets
325 mg Ferrous Sulfate tablets taken orally three times a day
IV Iron (standard of care)
IV standard of care (other IV iron) per the Investigator's discretion
Ferric Carboxymaltose (FCM)
A total maximum cumulative dose of 1500 mg administered on Days 0 and 7.

Locations

Country Name City State
United States Luitpold Pharmaceuticals, Inc. Norristown Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Luitpold Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mean Increase From Baseline to the Highest Observed Hemoglobin Value Between Baseline and Day 35 or Time of Intervention for Patients Taking FCM as Compared to That for Patients Taking Ferrous Sulfate. Day 35
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