Defective lymphatic vasculature as a cause of fluid retention by calcium channel blocker therapy in women after menopause.

Phase 1

• Conditions: Calcium channel antagonist induced peripheral edema in post-menopausal women. We hypothesize that this condition is partly due to impaired lymphatic function in these patients.; MedDRA version: 18.0Level: LLTClassification code 10067033Term: Drug side effectSystem Organ Class: 100000004867; Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]; MedDRA version: 18.0Level: LLTClassification code 10034570Term: Peripheral edemaSystem Organ Class: 100000004867

• Registration Number: EUCTR2015-001761-11-DK
• Lead Sponsor: The Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07-10
• Last Update Posted: 8 January 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 16

Inclusion Criteria

Healthy post-menopausal women, which means that it is 1 years since last menstruation and case of flushing.
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 8
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8

Exclusion Criteria

Exclusion criteria are arterial hypotension, orthostatic hypotension, angina pectoris, previous acute myocardial infarction, previous gastrointestinal bleeding, diabetes, currently in the treatment of any type of calcium channel blocker, ACE inhibitor or angiotensin-receptor blocker and allergy against anything contained in the tablets. Subjects stating unexplainable loss of consciousness during the last 5 years will also be excluded.

Study & Design

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