Efficacy/Safety Study of Valsartan and Chlorthalidone Conjugate Treatment Compared to Simple Treatment for Hypertension

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01850160
• Other study ID #: 005-12 HTA
• Status: Completed
• Phase: Phase 3
• First received: May 7, 2013
• Last updated: January 25, 2016
• Start date: April 2013
• Est. completion date: May 2015

Study information

• Verified date: March 2015
• Source: Farma de Colombia SA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y AlimentosEcuador: Public Health Ministry
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: May 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• GROUP A: Valsartan plus Chlorthalidone
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: Valsartan
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: Chlorthalidone
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.

Locations

Country	Name	City	State
Colombia	Fundacion Cardiomet Cequin	Armenia	Quindio
Colombia	MedPlus	Bogota DC
Colombia	Centro de Diagnostico Cardiologico	Cartagena	Bolivar
Ecuador	Centro AMCOR	Quito
Ecuador	Centro Clinico quirurgico	Quito
Ecuador	Centro médico de hipertensión arterial	Quito
Ecuador	Clínica DAME	Quito
Ecuador	Consultorio Edificio Novoa	Quito

Sponsors (1)

Lead Sponsor	Collaborator
Farma de Colombia SA

Countries where clinical trial is conducted

Colombia,  Ecuador, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Metabolic changes secondary to the treatment with Valsartan and Chlorthalidone, Vs Valsartan or Chlorthalidone	Identify if there are significant differences regarding metabolic changes secondary to the treatment with Valsartan and Chlorthalidone Vs Valsartan or Chlorthalidone.	12 weeks	No
Other	Incidence of adverse events in each intervention group	Determine the percentage of incidence of adverse events in each intervention group.	12 weeks	No
Primary	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	12 weeks	No
Secondary	Changes in Systolic and Diastolic Blood pressure values	Assess the changes in Systolic and Diastolic Blood Pressure from baseline up to week 12	12 weeks	No
Secondary	Changes of Systolic blood pressure values	Assess the changes of systolic blood pressure from baseline up to week 6 and 12	12 weeks	No
Secondary	Changes of Diastolic blood pressure values	Assess the changes of diastolic blood pressure from baseline up to week 6 and 12	12 weeks	No
Secondary	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	12 weeks	No
Secondary	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	12 weeks	No
Secondary	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	12 weeks	No
Secondary	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	12 weeks	No
Secondary	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	12 weeks	No