CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 233 enrolled
Drug / intervention
Amlodipine +4 moredrug
Likely dose
Amlodipine 5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03276598
NCT03276598Phase 4Completed

A Randomised Double-blind Cross-over Single-centre Study on Molecular Genetics of Drug Responsiveness in Essential Hypertension

Helsinki University Central Hospital·interventional·Posted Sep 8, 2017·Updated Sep 11, 2017

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

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFinland
Collaborators--

Timeline

Phase 4CompletedFinished
2000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 8, 2017
Enrollment StartNov 25, 1999
Primary CompletionApr 1, 2004
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 8.8 years ago

Interventions

Amlodipinedrug

Treatment for four weeks. Dose: 5 mg o.d.

Bisoprololdrug

Treatment for four weeks. Dose: 5 mg o.d.

Hydrochlorothiazidedrug

Treatment for four weeks. Dose: 25 mg o.d.

Losartandrug

Treatment for four weeks. Dose: 50 mg o.d.

Placebodrug

Treatment for four weeks. Dose: 1 tablet per day.