Efficacy/Safety Study of Valsartan and Chlorthalidone Conjugate Treatment Compared to Simple Treatment for Hypertension
Information source: Farma de Colombia SA
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: GROUP A: Valsartan plus Chlorthalidone (Drug); GROUP B: Valsartan (Drug); GROUP C: Chlorthalidone (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Farma de Colombia SA Official(s) and/or principal investigator(s): Juan D Romero, MD, Study Director, Affiliation: Farma de Colombia SA
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Safety and Efficacy of the fixed-dose combination treatment with Valsartan plus Chlorthalidone
Secondary outcome: Changes in Systolic and Diastolic Blood pressure valuesChanges of Systolic blood pressure values Changes of Diastolic blood pressure values Changes of diastolic blood pressure in arterial blood pressure median values Changes of systolic blood pressure values in arterial blood pressure median values Patient that achieving blood pressure values lower than 140/90 (systolic/diastolic) at week 6 and 12 Patients that achieving systolic blood pressure values lower than 140 at week 6 and 12 Patients that achieving diastolic blood pressure values lower than 90 at week 6 and 12
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
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
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.
Locations and Contacts
MedPlus, Bogota DC 11001, Colombia; Recruiting Andres E Rico, MD, Phone: (057) 1 5226772, Email: andresr@medplus.com.co Andres E Rico, MD, Principal Investigator Juan C Chavez, MD, Sub-Investigator
Centro AMCOR, Quito EC170150, Ecuador; Recruiting Ivan A Zuleta, MD, Phone: 0998313865, Email: ivanzuleta2001@yahoo.es Ivan A Zuleta, MD, Principal Investigator
Centro Clinico quirurgico, Quito EC170150, Ecuador; Recruiting Carlos R Chacon, MD, Phone: 0999663583, Email: cardioanalisis@gmail.com Carlos R Chacon, MD, Principal Investigator
Centro médico de hipertensión arterial, Quito EC170150, Ecuador; Recruiting Diego F Benitez, MD, Phone: 0992563809, Email: dbenitezapata@hotmail.com Diego F Benitez, MD, Principal Investigator
Clínica DAME, Quito EC170150, Ecuador; Recruiting Mayra D Sanchez, MD, Phone: 0996026583, Email: mayraisanzvelez@hotmail.com Mayra D Sanchez, MD, Principal Investigator
Consultorio Edificio Novoa, Quito EC170150, Ecuador; Recruiting Luis F Sanchez, MD, Phone: 0999738520, Email: lsanchez@pi.pro.ec Luis F Sanchez, MD, Principal Investigator
Centro de Diagnostico Cardiologico, Cartagena, Bolivar 130001, Colombia; Recruiting Fernando Manzur Jattin, MD, Phone: (057) 5 6652290, Email: coordinacion.cdc@hotmail.com Fernando Manzur Jattin, MD, Principal Investigator Luz E Cohen, MD, Sub-Investigator
Fundacion Cardiomet Cequin, Armenia, Quindio 630001, Colombia; Recruiting Gregorio Sanchez Vallejo, MD, Phone: (057) 7 8872600, Email: marthaadriana14@hotmail.com Gregorio Sanchez Vallejo, MD, Principal Investigator Andres Gallego Orozco, MD, Sub-Investigator
Additional Information
Starting date: April 2013
Last updated: May 9, 2013
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