At a glance
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A Randomised Double-blind Cross-over Single-centre Study on Molecular Genetics of Drug Responsiveness in Essential Hypertension
In Brief
A Phase 4 clinical trial evaluating Amlodipine, Bisoprolol, and 3 other interventions for Hypertension and Pharmacogenetics. Completed, enrolled 233 participants across 1 site.
Detailed Summary
Blood pressure variation and the risk of essential hypertension have an important genetic component. In most cases susceptibility to essential hypertension is likely determined by the action of more than one gene. The identification of genes causing susceptibility to hypertension is important, since it would give new tools for the diagnosis and enable better etiological classification and specific treatment of the disease. The innovation of this study is to use the response to antihypertensive therapy as an intermediate phenotype. In the study, each subject uses one of four antihypertensive drugs, each as a monotherapy in a rotational fashion, for 28 days in a randomized order. The antihypertensive drugs to be tested include a thiazide diuretic, a beta-adrenergic antagonist, an angiotensin-II receptor antagonist and a calcium channel blocker. The drugs that are selected for the study are "typical" representatives of their groups and long-acting, and the dosages are sufficient but well tolerable.
Study Details
Timeline
Interventions
Treatment for four weeks. Dose: 5 mg o.d.
Treatment for four weeks. Dose: 5 mg o.d.
Treatment for four weeks. Dose: 25 mg o.d.
Treatment for four weeks. Dose: 50 mg o.d.
Treatment for four weeks. Dose: 1 tablet per day.