Clinical trial NCT01850160: Efficacy/Safety Study of Valsartan and Chlorthalidone Conjugate Treatment Compared to Simple Treatment for Hypertension
Official title: Efficacy and Safety of the Fixed-dose Combination of Valsartan Plus Chlorthalidone Vs Valsartan or Chlorthalidone Alone in the Treatment of Arterial Hypertension, Open-label, Controlled, Randomized and Multicenter Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: Hypertension
High blood pressure
Drug therapy combination
Valsartan
Chlorthalidone
Safety
Efficacy
Lead sponsor: Farma de Colombia SA
Sponsor class: INDUSTRY
First posted: 2013-05-09
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Patient with diagnosis of arterial hypertension defined as:
* Systolic blood pressure greater or equal to 140 and lower than 180 mmHg
* Diastolic blood pressure greater or equal to 90 and lower than 110 mmHg
* Non controlled patients with antihypertensive treatment (blood pressure values: Systolic blood pressure \> 140 mmHg and/or Diastolic blood pressure \> 90 mmHg) or patients antihypertensive treatment-naïve.
* Likelihood of attending consultations according to the trial chronogram.
* Informed Consent Signature.

Exclusion Criteria:

* Diagnosis of severe or malignant arterial hypertension defined as:
* Systolic blood pressure greater or equal to 180 mmHg
* Diastolic blood pressure greater or equal to 110 mmHg
* Patients with secondary arterial hypertension of any etiology.
* Pregnant women or women with childbearing potential who are not using appropriate contraception methods; women planning to become pregnant during the trial.
* Patients with history of Acute Myocardial Infarction o Angina Pectoris within the 6 months prior to the trial initiation.
* Diagnosis of Cerebrovascular Disease (CVD) o Transient Ischemic Attack (TIA) within the 6 previous months.
* Patients with Severe Renal Disease defined by serum Creatinine levels higher than 1.5 mg/dl.
* Diagnosed or suspected unilateral or bilateral renal artery stenosis.
* History of non remitting cancer within the 5 years prior to the trial initiation.
* Patients with Hypokalemia or Hyperkalemia.
* Patients receiving Valsartan or Chlortalidone during the 14 previous days.
* Patients with known hypersensitivity to Valsartan or Chlorthalidone.
* Unstable patients with antecedent of hospitalization within the 4 days prior to their enrollment in the trial.
* Patients with history of drugs and alcohol abuse within the last year.
* Patients who have taken part in other clinical trial within the 4 weeks prior to the initiation of this research.
* Patients with any other clinical condition that the investigator deems may affect the patient follow-up.

Primary outcomes:
measure: Safety and Efficacy of the fixed-dose combination treatment with Valsartan plus Chlorthalidone
timeFrame: 12 weeks
Secondary outcomes:
measure: Changes in Systolic and Diastolic Blood pressure values
timeFrame: 12 weeks
measure: Changes of Systolic blood pressure values
timeFrame: 12 weeks
measure: Changes of Diastolic blood pressure values
timeFrame: 12 weeks
measure: Changes of diastolic blood pressure in arterial blood pressure median values
timeFrame: 12 weeks
measure: Changes of systolic blood pressure values in arterial blood pressure median values
timeFrame: 12 weeks
measure: Patient that achieving blood pressure values lower than 140/90 (systolic/diastolic) at week 6 and 12
timeFrame: 12 weeks
measure: Patients that achieving systolic blood pressure values lower than 140 at week 6 and 12
timeFrame: 12 weeks
measure: Patients that achieving diastolic blood pressure values lower than 90 at week 6 and 12
timeFrame: 12 weeks
Other outcomes:
measure: Metabolic changes secondary to the treatment with Valsartan and Chlorthalidone, Vs Valsartan or Chlorthalidone
timeFrame: 12 weeks
measure: Incidence of adverse events in each intervention group
timeFrame: 12 weeks
Locations:
city: Cartagena
country: Colombia
facility: Centro de Diagnostico Cardiologico
state: Bolivar
city: Armenia
country: Colombia
facility: Fundacion Cardiomet Cequin
state: Quindio
city: Bogota DC
country: Colombia
facility: MedPlus
city: Quito
country: Ecuador
facility: Centro AMCOR
city: Quito
country: Ecuador
facility: Centro Clinico quirurgico
city: Quito
country: Ecuador
facility: Centro médico de hipertensión arterial
city: Quito
country: Ecuador
facility: Clínica DAME
city: Quito
country: Ecuador
facility: Consultorio Edificio Novoa
Study officials:
affiliation: Farma de Colombia SA
name: Juan D Romero, MD
role: STUDY_DIRECTOR
References:
citation: Manzur F, Rico A, Romero JD, Rodriguez-Martinez CE. Efficacy and Safety of Valsartan or Chlorthalidone vs. Combined Valsartan and Chlorthalidone in Patients With Mild to Moderate Hypertension: The VACLOR Study. Clin Med Insights Cardiol. 2018 Sep 3;12:1179546818796482. doi: 10.1177/1179546818796482. eCollection 2018.