E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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. |
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E.1.1.1 | Medical condition in easily understood language |
Calcium channel-blockers is often used to treat high bloodpressure, as a side effect patients retains fluid in the legs. We think that this is somewhat due to a dysfunctional lymphatic vasculature. |
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E.1.1.2 | Therapeutic area | Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10067033 |
E.1.2 | Term | Drug side effect |
E.1.2 | System Organ Class | 100000004867 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10034570 |
E.1.2 | Term | Peripheral edema |
E.1.2 | System Organ Class | 100000004867 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The aim with this study is to investigate the mechanism behind the oedema development often associated with treatment of cardiovascular disease with calcium channel blockers. The current belief is that a preferential arterial over venous dilation leads to increased fluid filtration. We will test this concept by measuring capillary filtration, which surprisingly has never been done before. The current belief will furthermore be challenged by also measuring the lymphatic removal of interstitial fluid during treatment with calcium channel blockers. Lymph vessels could potentially be an off-target effect of the drugs and augment oedema formation. This might explain why some patients treated with these drugs develop oedemas.
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Healthy post-menopausal women, which means that it is 1 years since last menstruation and case of flushing. |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary end-points are: lymphatic contraction frequency, contraction wave velocity, lymphatic systolic pumping pressure, the time it takes for a vessel to refill after it has been emptied by manual massage and capillary fluid filtration rate. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Every single end point will first be evaluated after completion of the last subject trial. 28 weeks |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | |