Trials / Terminated
TerminatedNCT03371173
ORal IrON Supplementation With Ferric Maltol in Patients With Pulmonary Hypertension (ORION-PH-1)
A Pilot Study to Explore Preliminary Safety, Tolerability and Efficacy of ORal IrON Supplementation With Ferric Maltol in Treating Iron Deficiency in Patients With Pulmonary Hypertension and Iron Deficiency Anemia
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 22 (actual)
- Sponsor
- Hannover Medical School · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is an explorative, open-label, uncontrolled, single center study to explore the preliminary safety, tolerability and efficacy of oral ferric maltol in treating iron deficiency in patients with pulmonary hypertension and iron deficiency anemia.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ferric maltol 30 mg (Feraccru®) | Feraccru® 30 mg hard capsules will be used. Each capsule contains 30 mg iron (as ferric maltol), 91.5 mg of lactose, 0.5 mg of Allura Red AC (E129) and 0.3 mg Sunset Yellow FCF (E110) as excipients with known effects |
Timeline
- Start date
- 2018-03-27
- Primary completion
- 2020-03-19
- Completion
- 2020-03-19
- First posted
- 2017-12-13
- Last updated
- 2020-04-21
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT03371173. Inclusion in this directory is not an endorsement.