Lymphatic dysfunction as a cause of calcium channel blocker oedema

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-002622-75-DK

Enrollment

Registered

2013-05-21

Start date

2013-05-21

Completion date

Unknown

Last updated

2016-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fluid accumulation in the leg associated with calcium channel blocker therapy. MedDRA version: 16.0 Level: LLT Classification code 10067033 Term: Drug side effect System Organ Class: 100000004867 MedDRA version: 16.0 Level: LLT Classification code 10034570 Term: Peripheral edema System Organ Class: 100000004867

Interventions

Trade Name: Nifedipin Alternova Product Name: Nifedipin Alternova Pharmaceutical Form: Tablet INN or Proposed INN: NIFEDIPINE CAS Number: 21829-25-4 Concentration unit: mg milligram(s) Concentration t

Eligibility

Sex/Gender

Male

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Countries

Denmark

Contacts

Public ContactNiklas Telinius

Department of Cardiothoracic Surger

telinius@me.com4530238533

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026