Monocenter prospective open single-arm phase IV study of the effects of hawthorn extract WS® 1442 on arterial micro-vascular structure and macro-vascular function, persistance and erectile function of male patients with underlying cardiovascular disease and erectile dysfunctio

Phase 1

• Conditions: nderlying cardiovascular disease; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2014-001319-38-DE
• Lead Sponsor: Dr. Willmar Schwabe GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-08-28
• Study Completion: 2020-09-09
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 35

Inclusion Criteria

1. Male outpatients aged 50 years and older
2. Specialist diagnosis of underlying cardiovascular disease
a) heart insufficiency, maximum NYHA II
b) essential arterial hypertension or
c) clinically manifested atherosclerosis
3. Echocardiographic LVEF at rest = 40%
4. Basic therapy of underlying cardiovascular disease according to current guidelines
5. Unchanged basic therapy for at least 4 weeks
6. Erectile dysfunction (less than 22 Points in the International Index of Erectile Function)
7. Written informed consent
8. Willingness and ability to participate all study specific tasks
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

1. Unstable, severe or acute cardiovascular diseases (acute coronary syndrome, myocardial infarction, instable angina pectoris, hemodynamic valvular defect, hypertrophic obstructive cardiomyopathy, inflammatory cardiac diseases. Stroke, transient ischaemic attack, organ infarction) within the last three months
2. Tachyarrythmic atrial fibrillation
3. Increase of cardiovascular complaints in the last seven days
4. Antihypertensives from more than two substance classes (ACE-Inhibitors, angiotensin II receptor antagonists, diuretics, beta-blockers, calcium antagonists, direct vasodilators, central acting antihypertensives)
5. Treatment with digitalis
6. Treatment with hawthorn or another herbal cardiovascular medication
7. Treatment of erectile dysfunction
8. Hypersensitivity towards other ingredients of the study medication
9. Participation in other clinical trials within the last 12 weeks
10. Ankle-brachial-index < 0,9
11. Alcohol or drug abuse or dependence
12. Acute or severe generalized diseases in the last 4 weeks
13. Acute or chronic psychiatric diseases
14. Planned hospitalization during study participation
15. Contagious skin and venereal diseases
16. Other factors that prevent from study participation (e.g. acute psychosocial burden, insufficient understanding of the content and scope of the study, insufficient knowledge of German language)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified