Efficacy and Safety of Valsartan Plus Hydrochlorothiazide in Patients With Slight Hypertension and Target Organ Damage

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

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2008-12-31

Brief Summary

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Patients with slight increase in blood pressure levels have an increased cardiovascular risk. In particular this has been demonstrated also in subjects with high-normal blood pressure in whom an exaggerated blood pressure increase, during exercise, and structural left ventricular abnormalities have been shown. On the other hand, the last American and European guidelines for management of hypertension recommend more aggressive treatment in young-middle aged subjects to achieve a better control of cardiovascular risk due to blood pressure increase. In agreement with these recommendations the investigators share the idea that a good blood pressure control should be achieved not only at rest, but also during psycho-physical stress conditions that frequently occur during daily life. On this basis, the investigators decided to evaluate the efficacy and tolerability of the association of valsartan and hydrochlorothiazide (160 an 25 mg daily, respectively) in patients with high-normal blood pressure and first degree arterial hypertension with evidence of organ damage.

The aim of this study is to assess if an early and adequate therapy could bring to a better pressure control (even during physical activity) and a regression of organ damage without interfering with metabolism and erectile function

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Detailed Description

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Conditions

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Hypertension Ventricular Remodeling Erectile Dysfunctions

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

Valsartan 160mg plus HCT 25mg

Intervention Type DRUG

valsartan 160 mg once a day for 6 months plus hydrochlorothiazide 25 mg a tablet once a day for 6 months

Interventions

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Valsartan 160mg plus HCT 25mg

valsartan 160 mg once a day for 6 months plus hydrochlorothiazide 25 mg a tablet once a day for 6 months

Intervention Type DRUG

Other Intervention Names

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Corixil 160/25mg Cotareg 160/25mg

Eligibility Criteria

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Inclusion Criteria

* Aged 18-65
* Gender Males
* High-normal blood pressure (130-139 mmHg or 85-89 mmHg)
* First degree hypertension (140-159 mmHg or 90-99 mmHg)
* Cardiac remodeling (left ventricular concentric hypertrophy

Exclusion Criteria

* Coronary artery disease
* Secondary hypertension
* Diabetes mellitus
* Incapacity to perform ergometry test
* Anemia (Hb \< 12.5g/dL)
* Cardiac valve disease
* Arrhythmia

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No