Cardiodoron® vs. placebo for functional cardiovascular disorders (FCD)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Weleda AG

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

23 Jul 2024 → 19 Jan 2026

Decision date (initial)

2024-07-22

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy, Others

Identification of suitable endpoints to show superiority of Cardiodoron® vs. placebo; identification of effect size of Cardiodoron® vs. placebo; evaluation of safety of Cardiodoron®

Conditions and MedDRA coding

functional cardiovascular disorders

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Patients of all sexes ≥ 18 to ≤ 80 years
2. Presence of FCD with/without sleeping disorders
3. Medium FCD severity (VAS ≥ 4 (out of 10))
4. Female patients of childbearing potential using highly efficient contraceptive methods
5. Willing and able to follow the trial assessments and trial procedure for the entire trial duration
6. Signed informed consent prior to any trial-related procedure

Exclusion criteria 15

1. Known organic cause of complaints (FCD with/without sleeping disorders)
2. Pathological finding in current ECG
3. 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)
4. Administration of not permitted therapy
5. Known active hepatitis B or C infection
6. Known existing relevant somatic condition (e.g. severe impaired renal function, severe liver disease, severe pulmonary disease, severe long/post COVID)
7. History of or known existing relevant psychiatric disorder (e.g. schizophrenia, psychosis, manic disorders, suicidal ideations, severe depressive disorders)
8. 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
9. Known allergic reactions to the active ingredients or constituents of the IMP
10. Any condition that interferes with the participation in the clinical trial at the discretion of the investigator (e.g. known drug or alcohol abuse)
11. Pregnant or lactating women
12. Patients in custody by judicial or official order
13. Patients who are unable to understand the written and verbal instructions (provided in German)
14. Patients who are staff of the trial site, staff of the Sponsor or CRO or of the trial team
15. 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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 15

1. Baseline adjusted difference in (mean) change from baseline in FCD severity measured by VAS at V3 and V4 (verum compared to placebo)
2. Baseline adjusted difference in (mean) change from baseline in Symptom Score (von Zerssen List B-LR and B-LR’ (sum score of both lists)) at V3 and V4 (verum compared to placebo)
3. Baseline adjusted difference in (mean) change from baseline in (sum) score (GBB-24) at V3 and V4 (verum compared to placebo)
4. Baseline adjusted difference in (mean) change from baseline in quality of life (SF-36; physical health and mental health summary measures) at V3 and V4
5. Proportion of patients with optimal blood pressure, normotony, high normal blood pressure, hypotension, hypertension (grade 1 3) at V2, V3 and V4
6. Proportion of patients showing improvements in symptoms (von Zerssen List B-LR and B-LR’ (sum score of both lists)) of 15% or more at treatment end/V4
7. Proportion of patients who discontinue the trial due to lack of efficacy
8. Baseline adjusted difference in (mean) change from baseline in Pittsburgh Sleep Quality Index (PSQI) at V3 and V4
9. Proportion of patients who are very satisfied, satisfied, unsatisfied, very unsatisfied with the efficacy of the IMP
10. Proportion of patients for whom investigator is very satisfied, satisfied, unsatisfied, very unsatisfied with the efficacy of the IMP
11. Number, nature (term), causality, severity and seriousness of adverse events
12. Clinically relevant change in laboratory parameters (blood) at V4 vs. baseline
13. Proportion of patients who discontinue the trial due to an adverse event
14. Proportion of patients who are very satisfied, satisfied, unsatisfied, very unsatisfied with the tolerability of the IMP
15. Proportion of patients for whom investigator is very satisfied, satisfied, unsatisfied, very unsatisfied with the tolerability of the IMP

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Weleda AG

Sponsor organisation

Weleda AG

Address

Dychweg 14

City

Arlesheim

Postcode

4144

Country

Switzerland

Scientific contact point

Organisation

Weleda AG

Contact name

Telephone switchboard

Public contact point

Organisation

Weleda AG

Contact name

central contact for clinical trials

Third parties 1

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 9 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications