Status:
COMPLETED
Efficacy/Safety Study of Valsartan and Chlorthalidone Conjugate Treatment Compared to Simple Treatment for Hypertension
Lead Sponsor:
Farma de Colombia SA
Conditions:
Hypertension
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
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 d...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT01850160
Start Date
April 1 2013
End Date
May 1 2015
Last Update
January 26 2016
Active Locations (8)
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1
MedPlus
Bogota DC, Bogota DC, Colombia, 11001
2
Centro de Diagnostico Cardiologico
Cartagena, Departamento de Bolívar, Colombia, 130001
3
Fundacion Cardiomet Cequin
Armenia, Quindío Department, Colombia, 630001
4
Centro AMCOR
Quito, Ecuador, EC170150