This trial is aimed to assess the efficacy and safety of a fixed-dose combination therapy with Valsartan and Chlorthalidone, Vs Valsartan or Chlorthalidone alone for treatment of adult patients with diagnosis of arterial hypertension.
In spite of the existence of a great variety of treatments with drugs effective against arterial hypertension, the percentages of arterial hypertension control with monotherapy remain quite low reason why the fixed-dose combinations of drugs have been one of the most interesting research topics in order to achieve an appropriate control of arterial hypertension. The possibility of achieving better coverage and Blood Pressure control through a drug combination has leaded, on a scientific base of the efficacy of an Angiotensin Receptor Blockers II plus diuretic combination, to the development of a great number of combinations with different Angiotensin II Receptor Blockers plus hydrochlorothiazide. Yet it is noteworthy that despite the increasing evidence showing additional benefits in Blood pressure control and reduction of cardiovascular outcomes with chlorthalidone over hydrochlorothiazide, there is neither a great number of combinations nor studies with Angiotensin II Receptor Blockers plus chlorthalidone whereby the conduction of a trial assessing the efficacy and safety of Valsartan plus chlorthalidone in hypertensive patients is proposed plus the benefits of combination therapy that include, among others, the greater efficacy with lower doses of each individual component as well as reduction in occurrence of adverse events directly related with lower drug doses.With this treatment schedule it is expected to obtain higher control of blood pressure values and greater percentage of patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
124
Combination therapy of Valsartan plus Chlorthalidone: Valsartan 80 mg / Chlorthalidone 12,5 mg. Once daily during 12 weeks. If the goals of blood Pressure are uncontrolled at week 6, the dose will be increase to Valsartan 160 mg / Chlorthalidone 25 mg once daily.
GROUP B: Treatment monotherapy: Valsartan 80 mg once daily during 12 weeks. If the goals of blood Pressure are uncontrolled at week 6, the dose will be increase to Valsartan 160 mg once daily.
GROUP C: Treatment monotherapy: Chlorthalidone 12,5 mg once daily during 12 weeks. If the goals of blood pressure are uncontrolled at week 6, the dose will be increase to Chlorthalidone 25 mg once daily.
MedPlus
Bogota DC, Bogota DC, Colombia
Centro de Diagnostico Cardiologico
Cartagena, Departamento de Bolívar, Colombia
Fundacion Cardiomet Cequin
Armenia, Quindío Department, Colombia
Centro AMCOR
Quito, Ecuador
Safety and Efficacy of the fixed-dose combination treatment with Valsartan plus Chlorthalidone
Efficacy and safety of a fixed-dose combination treatment of Valsartan plus Chlorthalidone Vs Valsartan or Chlorthalidone alone in the treatment of patients with arterial hypertension
Time frame: 12 weeks
Changes in Systolic and Diastolic Blood pressure values
Assess the changes in Systolic and Diastolic Blood Pressure from baseline up to week 12
Time frame: 12 weeks
Changes of Systolic blood pressure values
Assess the changes of systolic blood pressure from baseline up to week 6 and 12
Time frame: 12 weeks
Changes of Diastolic blood pressure values
Assess the changes of diastolic blood pressure from baseline up to week 6 and 12
Time frame: 12 weeks
Changes of diastolic blood pressure in arterial blood pressure median values
Assess the changes in diastolic blood pressure in Arterial Blood Pressure Media from baseline up to week 12
Time frame: 12 weeks
Changes of systolic blood pressure values in arterial blood pressure median values
Assess the change in systolic blood pressure in Arterial Blood Pressure Median from baseline up to week 12
Time frame: 12 weeks
Patient that achieving blood pressure values lower than 140/90 (systolic/diastolic) at week 6 and 12
Determine the percentage of patients achieving blood pressure values lower than 140/90 (systolic/diastolic) at weeks 6 and 12
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Centro Clinico quirurgico
Quito, Ecuador
Centro médico de hipertensión arterial
Quito, Ecuador
Clínica DAME
Quito, Ecuador
Consultorio Edificio Novoa
Quito, Ecuador
Time frame: 12 weeks
Patients that achieving systolic blood pressure values lower than 140 at week 6 and 12
Determine the percentage of patients achieving systolic blood pressure lower than 140 at weeks 6 and 12
Time frame: 12 weeks
Patients that achieving diastolic blood pressure values lower than 90 at week 6 and 12
Determine the percentage of patients achieving diastolic blood pressure lower than 90 at week 6 and 12
Time frame: 12 weeks