A Study on Molecular Genetics of Drug Responsiveness in Essential Hypertension

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

233 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-11-25

Study Completion Date

2004-04-01

Brief Summary

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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.

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Detailed Description

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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. Finland is an ideal place for a study like this because of the genetic homogeneity of the population, the relatively high prevalence of the disease and the established protocols for the treatment and follow-up of hypertension in public health care.

The molecular genetic studies on hypertension performed so far (by 1999) have primarily been association studies, which are based on case-control classification and may produce erroneous results. Particularly, a reliable phenotyping of cases and controls has been difficult. Consequently, more attention should be paid to the phenotyping of patients, and novel intermediate phenotypes characteristic of certain subtypes of hypertension should be used to facilitate the search for hypertension genes. 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. The study design does not necessitate the use of equipotent doses of the various agents, since the study is not designed to compare the antihypertensive effectiveness of the study drugs or, due to the short treatment periods, their effects on clinical endpoints.

Conditions

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Hypertension Pharmacogenetics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

The design of the study is a randomized placebo-controlled cross-over study. The study starts with a run-in placebo period lasting for four weeks. The four monotherapy treatment periods last for four weeks and they are separated by placebo periods lasting also for four weeks. Randomization occurs after the first placebo period in blocks of 24 (all possible drug sequences).

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

The placebo tablets and drugs are packed in similar gelatin capsules.

Study Groups

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Amlodipine

One of the four monotherapy treatment periods.

Group Type ACTIVE_COMPARATOR

Amlodipine

Intervention Type DRUG

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

Bisoprolol

One of the four monotherapy treatment periods.

Group Type ACTIVE_COMPARATOR

Bisoprolol

Intervention Type DRUG

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

Hydrochlorothiazide

One of the four monotherapy treatment periods.

Group Type ACTIVE_COMPARATOR

Hydrochlorothiazide

Intervention Type DRUG

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

Losartan

One of the four monotherapy treatment periods.

Group Type ACTIVE_COMPARATOR

Losartan

Intervention Type DRUG

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

Placebo

Placebo treatment period.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Amlodipine

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

Intervention Type DRUG

Bisoprolol

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

Intervention Type DRUG

Hydrochlorothiazide

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

Intervention Type DRUG

Losartan

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* essential hypertension diagnosed on an earlier occasion or during the present study (three diastolic blood pressure readings \>=95 mmHg on separate occasions are required).

Exclusion Criteria

* usage of three or more antihypertensive drugs
* secondary hypertension
* left ventricular hypertrophy
* drug-treated diabetes mellitus
* coronary heart disease
* stroke and other disorders of cerebral circulation
* renal disease
* obstructive pulmonary disease
* a disease treated with corticosteroids
* a disease with drug treatment potentially influencing blood pressure levels
* significant obesity (BMI \>=32 kg/m2)
* allergic reaction towards any of the study drugs
* The patient is excluded from the study if his blood pressure level rises to 200/120 mmHg or above during the study.

Minimum Eligible Age

35 Years

Maximum Eligible Age

59 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No