CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 267 enrolled
Drug / intervention
Ferrum Lek® (iron (III) hydroxide polymaltosate), 100 mg chewable tablets (Lek d.d., Slovenia) +1 moredrug
Likely dose
Ferrum Lek® (iron (III) hydroxide polymaltosate), 100 mg chewable tablets (Lek d.d., Slovenia)from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03993288
NCT03993288Phase 3Completed
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Multicenter, Open-label Active-controlled Randomized Study of Efficacy and Safety of Ferrum Lek® (Iron (III) Hydroxide Polymaltosate), 100 mg Chewable Tablets (Lek d.d., Slovenia) Compared With Maltofer® (Iron (III) Hydroxide Polymaltosate), 100 mg Chewable Tablets (Vifor S.A., Switzerland), in Treatment of Patients With Mild and Moderate Iron-deficiency Anaemia.

Sandoz·interventional·Posted Jun 20, 2019·Updated Jul 12, 2021

In Brief

A Phase 3 clinical trial evaluating Ferrum Lek® (iron (III) hydroxide polymaltosate), 100 mg chewable tablets (Lek d.d., Slovenia) and MALTOFER® (iron (III) hydroxide polymaltosate), 100 mg chewable tablets (Vifor S.A., Switzerland) for Mild and Moderate Iron-deficiency Anaemia. Completed, enrolled 267 participants across 18 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMild and Moderate Iron-deficiency Anaemia
CountriesRussia
Collaborators--

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedJun 20, 2019
Enrollment StartJun 27, 2019
Primary CompletionJun 18, 2020
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 7.0 years ago

Interventions

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

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

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

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