Treatment of Adiposity Related hypErTension (TARGET)

Summary

High blood pressure (hypertension) is an important cause of myocardial infarction and stroke. High blood pressure often occurs in people who are overweight. These people frequently also have abnormal fat and sugar metabolism. The combination of these problems is called the 'metabolic syndrome'.

People with hypertension and obesity currently receive the same drug therapy as people with hypertension, but without obesity. Different classes of drugs are thought to be equally effective in lowering blood pressure.

Next to lowering blood pressure, hypertension treatment can have additional effects, like changes in blood vessel function (the ability to dilate and constrict) or changes is the metabolism of sugar and fat. Particularly in patients with the metabolic syndrome, these additional effects are thought to be of great importance, because they can influence the risk for cardiovascular diseases.

The blood pressure lowering mechanism differs between classes of blood pressure lowering medication. The purpose of this study is to compare the effects of three types of blood pressure lowering medication belonging to different classes. The main outcomes of interest will be blood vessel function (the ability to dilate and constrict) and blood pressure. Moreover, the effect of treatment on additional outcomes, like metabolism of sugar and fat, will be studied.

Conditions

• Hypertension
• Abdominal Obesity
• Metabolic Syndrome

Interventions

DRUG

Aliskiren

Once daily treatment with aliskiren for 8-weeks, according to the following regiment: once daily (morning time) 150 mg during the first 2 weeks, followed by once daily (morning time) 300 mg during the remaining 6 weeks. Coincidental intake of grapefruit(juice) should be avoided. This treatment interval is followed by a one-week tapering period: 150 mg on day 1, 2, 3, 4, 5 and 7.

DRUG

Moxonidine

Once daily treatment with moxonidine for 8-weeks, according to the following regiment: once daily (morning time) 0.2 mg during the first 2 weeks, followed by once daily (morning time) 0.4 mg during the remaining 6 weeks. Coincidental intake of grapefruit(juice) should be avoided. This treatment interval is followed by a one-week tapering period: 0.2 mg on day 1, 2, 3, 4, 5 and 7.

DRUG

Hydrochlorothiazide

Once daily treatment with hydrochlorothiazide for 8-weeks, according to the following regiment: once daily (morning time) 12.5 mg during the first 2 weeks, followed by once daily (morning time) 25 mg during the remaining 6 weeks. Coincidental intake of grapefruit(juice) should be avoided. This treatment interval is followed by a one-week tapering period: 12.5 mg on day 1, 2, 3, 4, 5 and 7.

DRUG

Placebo (for aliskiren)

Once daily treatment with placebo tablets for 8-weeks, according to the following regiment: once daily (morning time) 1 tablet during the first 2 weeks, followed by once daily (morning time) 2 tablets during the remaining 6 weeks. Coincidental intake of grapefruit(juice) should be avoided. This treatment interval is followed by a one-week tapering period: 1 tablet on day 1, 2, 3, 4, 5 and 7.

DRUG

Placebo (for moxonidine and hydrochlorothiazide)

Once daily treatment with placebo capsules for 8-weeks, according to the following regiment: once daily (morning time) 1 capsule during the first 2 weeks, followed by once daily (morning time) 2 capsules during the remaining 6 weeks. Coincidental intake of grapefruit(juice) should be avoided. This treatment interval is followed by a one-week tapering period: 1 tablet on day 1, 2, 3, 4, 5 and 7.

Sponsors & Collaborators

• Novartis Pharmaceuticals

  collaborator INDUSTRY

• UMC Utrecht

  lead OTHER

Principal Investigators

• F.L.J. Visseren, Professor (MD PhD) · UMC Utrecht

• W. Spiering, MD PhD · UMC Utrecht

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

CROSSOVER

Eligibility

Min Age

30 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-08-31

Primary Completion

2012-02-29

Completion

2012-02-29

Countries

• Netherlands

Study Locations