Stage II arterial Hypertension
Conditions
Interventions
Trade Name: COZAAR PLUS
Product Name: COZAAR PLUS (losartán / hydrochlorothiazide)
Pharmaceutical Form: Tablet
Sponsors
Catalan Society of Family Medicine, represented by Dr Mariano de la Figuera Von Wichman and Gabriel
Eligibility
Sex/Gender
All
Inclusion criteria
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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess if inicial and titration therapy with a combined fixed dose ise superior to inicial and titration monotherapy in stage II hipertensión on: Lowering blood pressure at week 24 Percentage of control at week 24 Time from begining of treatment to control of blood pressure ;Secondary Objective: To assess if inicial and titration therapy with a combined fixed dose ise superior to inicial and titration monotherapy in stage II hipertensión on: Lowering blood pressure at week 12 Percentage of control at week 12 To assess if inicial and titration therapy with a combined fixed dose ise superior to inicial and titration monotherapy in stage II hipertensión on: quality of life patient´s adherence secondary effects Lowering blood pressure at week 24 Percentage of control at week 24 Time from begining of treatment to control of blood pressure ;Primary end point(s): Blood pressure at week 24 Percentage of control at week 24 Time from begining of treatment to control of blood pressure | — |
Countries
Spain
Outcome results
None listed