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Study to Test the Hypothesis of Non-inferior Efficacy and Safety of Ferrum Lek® (Iron (III) Hydroxide Polymaltosate), 100 mg Chewable Tablets (Lek d.d., Slovenia), as Compared With MALTOFER® (Vifor S.A., Switzerland), in Subjects With Mild and Moderate Iron Deficiency Anemia.

NCT03993288 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 267

Last updated 2021-07-12

Study results available
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Summary

The purpose of this study was to evaluate non-inferiority for efficacy and safety of Ferrum Lek® (iron (III) hydroxide polymaltosate), 100 mg chewable tablets (Lek d.d., Slovenia), compared to MALTOFER® (Vifor S.A., Switzerland), in the treatment of patients with mild and moderate iron-deficiency anaemia.

Conditions

  • Mild and Moderate Iron-deficiency Anaemia

Interventions

DRUG

Ferrum Lek® (iron (III) hydroxide polymaltosate), 100 mg chewable tablets (Lek d.d., Slovenia)

Participants received Ferrum Lek® 2 tablets daily (200 mg) for 12 weeks

DRUG

MALTOFER® (iron (III) hydroxide polymaltosate), 100 mg chewable tablets (Vifor S.A., Switzerland)

Participants received MALTOFER® 2 tablets daily (200 mg) for 12 weeks

Sponsors & Collaborators

Principal Investigators

  • Sandoz · Sandoz

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-27
Primary Completion
2020-06-18
Completion
2020-06-18

Countries

  • Russia

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03993288 on ClinicalTrials.gov