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ESTRATEGIAS PARA EL TRATAMIENTO DE LA HIPERTENSIÓN ARTERIAL. EVALUACIÓN DE UNA TERAPIA COMBINADA A DOSIS FIJAS (LOSARTÁN/HIDROCLOROTIAZIDA) vs MONOTERAPIA (ESTRATAAR).(STRATEGIES FOR THE TREATMENT OF ARTERIAL HYPERTENSION. ASSESSMENT OF A COMBINED THERAPY AT FIXED DOSES (LOSARTAN/HYDROCHOLOTHIAZIDE) vs MONOTHERAPY (ESTRATAAR) - ESTRATAAR

Conditions
Stage II arterial Hypertension
Registration Number
EUCTR2004-002020-17-ES
Lead Sponsor
Catalan Society of Family Medicine, represented by Dr Mariano de la Figuera Von Wichman and Gabriel
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Authorised-recruitment may be ongoing or finished
Sex
All
Target Recruitment
140
Inclusion Criteria

1. Patients diagnosed of stage II arterial hipertensión (JNC7, BP>160/100), currently without therapy, or under monotherapy al teast 4 weeks who have not reaches BP control.
2. For diabetic patients BP to be included will be >150/90.
3. White coat hypertension has been excluded (Ambulatory BP Monitorization)
4. Informed consent.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Patient denies to participate.
2. Patient is not an adult, of has not a mental condition to understannd protocol procedures and collaborate.
3. Non complaints.
4. Alcohol or drug abuse.
5. Pregnant women or breastfeeding period, or women who foresee to become pregnant
6. Secondary hypertension (suspected or confirmed)
7. White coat hypertension
8. Combined therapy is needed due to patient´s clinical condition.
9. Presence of cardiovascular disease.
10. Renal damage (Creatinine > 1,2 (women) y 1,5 (men)).
11. Liver disease (serum transaminases > 3 times upper limit, or chronic liver disease).
12. High serum potassium (>5,5)
13. Severe current disease (cancer, degenerative..)
14. Patients currently treated and controlled
15. Patients not controlled under combination theraphy.
16. Very high BP (>200/110)
17. Intolerance, allergy or contraindication to study medication (ARB and diuretics)

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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