Cardiodoron® vs. placebo for functional cardiovascular disorders (FCD)
- Conditions
- functional cardiovascular disordersMedDRA version: 21.0Level: PTClassification code: 10078078Term: Cardiovascular somatic symptom disorder Class: 100000004873Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- CTIS2024-511210-21-00
- Lead Sponsor
- Weleda AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 125
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method