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Cardiodoron® vs. placebo for functional cardiovascular disorders (FCD)
EU CTIS ID: 2024-511210-21-00
What this study is testing
Identification of suitable endpoints to show superiority of Cardiodoron® vs. placebo; identification of effect size of Cardiodoron® vs. placebo; evaluation of safety of Cardiodoron®
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients of all sexes ≥ 18 to ≤ 80 years
- Presence of FCD with/without sleeping disorders
- Medium FCD severity (VAS ≥ 4 (out of 10))
- Female patients of childbearing potential using highly efficient contraceptive methods
- Willing and able to follow the trial assessments and trial procedure for the entire trial duration
- Signed informed consent prior to any trial-related procedure
You likely can't join if
- Known organic cause of complaints (FCD with/without sleeping disorders)
- Any condition that interferes with the participation in the clinical trial at the discretion of the investigator (e.g. known drug or alcohol abuse)
- Pregnant or lactating women
- Patients in custody by judicial or official order
- Patients who are unable to understand the written and verbal instructions (provided in German)
- Patients who are staff of the trial site, staff of the Sponsor or CRO or of the trial team
See the full eligibility criteria
- Patients of all sexes ≥ 18 to ≤ 80 years
- Presence of FCD with/without sleeping disorders
- Medium FCD severity (VAS ≥ 4 (out of 10))
- Female patients of childbearing potential using highly efficient contraceptive methods
- Willing and able to follow the trial assessments and trial procedure for the entire trial duration
- Signed informed consent prior to any trial-related procedure
- Known organic cause of complaints (FCD with/without sleeping disorders)
- Any condition that interferes with the participation in the clinical trial at the discretion of the investigator (e.g. known drug or alcohol abuse)
- Pregnant or lactating women
- Patients in custody by judicial or official order
- Patients who are unable to understand the written and verbal instructions (provided in German)
- Patients who are staff of the trial site, staff of the Sponsor or CRO or of the trial team
- Concurrent participation in another clinical trial or administration of an IMP in another clinical trial within 3 months prior to screening visit 1 or within five half-lives, whichever is longer
- Pathological finding in current ECG
- Known existing cardiac diseases: a. heart insufficiency NYHA I-IV b. known existing cardiac valve vitium requiring treatment c. any unstable cardiac disease d. any other cardiac disease which is not treated according to medical guidelines or medical practice (in the absence of a guideline)
- Administration of not permitted therapy
- Known active hepatitis B or C infection
- Known existing relevant somatic condition (e.g. severe impaired renal function, severe liver disease, severe pulmonary disease, severe long/post COVID)
- History of or known existing relevant psychiatric disorder (e.g. schizophrenia, psychosis, manic disorders, suicidal ideations, severe depressive disorders)
- History of or known existing malignancy during the past 5 years before screening visit 1 except for history of basal cell carcinoma and melanoma in situ
- Known allergic reactions to the active ingredients or constituents of the IMP
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.