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

• Status: Completed
• Trial end date: 2015-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Farma de Colombia SA
• Treatments: Angiotensin II; Angiotensin Receptor Antagonists; Antihypertensive Agents; Chlorthalidone; Diuretics; Sodium Chloride Symporter Inhibitors; Valsartan

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.