ymphatic dysfunction as a cause of calcium channel blocker oedema
Phase 1
- Conditions
- Fluid accumulation in the leg associated with calcium channel blocker therapy.MedDRA version: 16.0Level: LLTClassification code 10067033Term: Drug side effectSystem Organ Class: 100000004867MedDRA version: 16.0Level: LLTClassification code 10034570Term: Peripheral edemaSystem Organ Class: 100000004867Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2012-002622-75-DK
- Lead Sponsor
- Vibeke Hjortdal
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 6
Inclusion Criteria
Male
18-35 years old
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 6
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
hypotension, orthostatic hypotension, angina pectoris, previous acute myocardial infarction, previous gastrointestinal bleeding, currently in treatment of any type of calcium channel blocker or allergy against anything in the tablets.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Investigate if calcium channel blocker nifedipin alternova affects parameters reflecting lymphatic transport;Secondary Objective: not applicable;Primary end point(s): Contraction frequency, contraction wave propagation velocity, maximal occlusion pressure and refill time under normal conditions;Timepoint(s) of evaluation of this end point: 12 days
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Contraction frequency, contraction wave propagation velocity, maximal occlusion pressure and refill time after an one hour immersion of the lower leg in a 40 degree water bath.;Timepoint(s) of evaluation of this end point: 12 days