A Double-blind, Double-dummy, Parallel, Active-controlled, Randomized Trial to Evaluate Efficacy & Safety in Anemia Subjects

• Conditions: Iron Deficiency Anemia; MedDRA version: 17.1Level: LLTClassification code 10022974Term: Iron deficiency anemiaSystem Organ Class: 100000004851; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2014-004380-20-Outside-EU/EEA
• Lead Sponsor: Sanol GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02-10
• Last Update Posted: 16 February 2015

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

An iron deficiency anemia patient with Serum Ferritin < 12 ng/mL, serum Hb-values >60 and < 120 g/L in males, < 110 g/L in females
Are the trial subjects under 18? yes
Number of subjects for this age range: 10
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 190
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

- With any Mal-absorption Syndrome
- With a history of Thalassemia or Sickle Cell Anemia
- With untreated concurrent Vitamin B12 or Folate deficiency at Baseline

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified