Efficacy/Safety Study of Valsartan and Chlorthalidone Conjugate Treatment Compared to Simple Treatment for Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): GROUP A: Valsartan plus Chlorthalidone; GROUP B: Valsartan; GROUP C: Chlorthalidone
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 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.
Other intervention name(s): Chlorthalidone Drug Combination; Valsartan Drug Combination; Antihypertensive Agents; Angiotensin II Receptor Antagonist; Antihypertensive Agents; Sodium Chloride Symporter Inhibitors; Antihypertensive Agents; Diuretics
Intervention MeSH terms: Valsartan; Antihypertensive Agents; Chlorthalidone; Angiotensin II; Angiotensin Receptor Antagonists; Diuretics; Sodium Chloride Symporter Inhibitors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hypertension; High blood pressure; Drug therapy combination; Valsartan; Chlorthalidone; Safety; Efficacy