Non-Interventional Study of Ferretab® Comp. (Ferrous Fumarate + Folic Acid Prolonged-Release Capsules) Effects in Adult Patients With Iron Deficiency Anemia and Cardiovascular Disease

Sponsor
Alcea
Study ID
NCT07753031
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

The goal of this observational study is to learn how well Ferretab® comp. works and how safe it is for adults with iron deficiency anemia and cardiovascular disease who are receiving treatment as part of their usual medical care. The main questions it aims to answer are: * Does treatment with Ferretab® comp. improve anemia? * Does treatment with Ferretab® comp. improve heart-related symptoms, exercise tolerance, and overall well-being? * What side effects do participants have while taking Ferretab® comp.? This is a non-interventional study. Participants will receive Ferretab® comp. because their doctor has already decided to prescribe it as part of routine medical care. Ferretab® comp. is an oral medicine that contains iron (as iron fumarate) and folic acid. The study will not change their treatment. Participants will: * Take Ferretab® comp. for 12 weeks as prescribed by their doctor. * Attend study visits at the start of treatment, after about 4 weeks, and after about 12 weeks. * Have routine blood tests and health assessments during the study. * Report any side effects and record information in a patient diary. * Answer questions about their symptoms, exercise tolerance, and how easy the treatment is to use.

Key Dates

First listed
Aug 7, 2026
Start date
Sep 30, 2026
Status verified
Aug 2026
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
389 participants (estimated)

Arms

  • Arm: Ferretab® comp.
    Adults with iron deficiency anemia (IDA) and concomitant cardiovascular disease (CVD) receiving treatment with Ferretab® comp. under routine clinical practice. Ferretab® comp. is an oral capsule containing iron fumarate (equivalent to 50 mg elemental iron) and 500 mcg folic acid.

Primary Outcome Measure

Absolute change in hemoglobin level at Week 12 [ Time Frame: From baseline (before treatment with Ferretab® comp.) to 12 weeks after treatment initiation (Visit 2) ]

Central Contacts

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