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.

PHASE3CompletedINTERVENTIONAL
Enrollment

267

Participants

Timeline

Start Date

June 27, 2019

Primary Completion Date

June 18, 2020

Study Completion Date

June 18, 2020

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

Trial Locations (18)

119121

Sandoz Investigative Site, Moscow

143408

Sandoz Investigative Site, Krasnogorsk

150003

Sandoz Investigative Site, Yaroslavl

188643

Sandoz Investigative Site, Saint Petersburg

191186

Sandoz Investigative Site, Saint Petersburg

192177

Sandoz Investigative Site, Saint Petersburg

193232

Sandoz Investigative Site, Saint Petersburg

194354

Sandoz Investigative Site, Saint Petersburg

194356

Sandoz Investigative Site, Saint Petersburg

195197

Sandoz Investigative Site, Saint Petersburg

196143

Sandoz Investigative Site, Saint Petersburg

197706

Sandoz Investigative Site, Saint Petersburg

198207

Sandoz Investigative Site, Saint Petersburg

198328

Sandoz Investigative Site, Saint Petersburg

199178

Sandoz Investigative Site, Saint Petersburg

199226

Sandoz Investigative Site, Saint Petersburg

199406

Sandoz Investigative Site, Saint Petersburg

214019

Sandoz Investigative Site, Smolensk

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Sandoz

INDUSTRY