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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Farma de Colombia SA
Sponsor:
Information provided by (Responsible Party):
Farma de Colombia SA
ClinicalTrials.gov Identifier:
NCT01850160
First received: May 7, 2013
Last updated: May 9, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Hypertension
Drug: GROUP A: Valsartan plus Chlorthalidone
Drug: GROUP B: Valsartan
Drug: GROUP C: Chlorthalidone
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Farma de Colombia SA:

Primary Outcome Measures:
  • Safety and Efficacy of the fixed-dose combination treatment with Valsartan plus Chlorthalidone [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Changes in Systolic and Diastolic Blood pressure values [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Assess the changes in Systolic and Diastolic Blood Pressure from baseline up to week 12

  • Changes of Systolic blood pressure values [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Assess the changes of systolic blood pressure from baseline up to week 6 and 12

  • Changes of Diastolic blood pressure values [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Assess the changes of diastolic blood pressure from baseline up to week 6 and 12

  • Changes of diastolic blood pressure in arterial blood pressure median values [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Assess the changes in diastolic blood pressure in Arterial Blood Pressure Media from baseline up to week 12

  • Changes of systolic blood pressure values in arterial blood pressure median values [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Assess the change in systolic blood pressure in Arterial Blood Pressure Median from baseline up to week 12

  • Patient that achieving blood pressure values lower than 140/90 (systolic/diastolic) at week 6 and 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Determine the percentage of patients achieving blood pressure values lower than 140/90 (systolic/diastolic) at weeks 6 and 12

  • Patients that achieving systolic blood pressure values lower than 140 at week 6 and 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Determine the percentage of patients achieving systolic blood pressure lower than 140 at weeks 6 and 12

  • Patients that achieving diastolic blood pressure values lower than 90 at week 6 and 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Determine the percentage of patients achieving diastolic blood pressure lower than 90 at week 6 and 12


Other Outcome Measures:
  • Metabolic changes secondary to the treatment with Valsartan and Chlorthalidone, Vs Valsartan or Chlorthalidone [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Identify if there are significant differences regarding metabolic changes secondary to the treatment with Valsartan and Chlorthalidone Vs Valsartan or Chlorthalidone.

  • Incidence of adverse events in each intervention group [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Determine the percentage of incidence of adverse events in each intervention group.


Estimated Enrollment: 124
Study Start Date: April 2013
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GROUP A: Valsartan plus Chlorthalidone
GROUP A: Combination therapy of Valsartan plus Chlorthalidone. Valsartan 80 mg/Chlorthalidone 12,5 mg. Once daily during 12 weeks.
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.
Other Names:
  • Chlorthalidone Drug Combination
  • Valsartan Drug Combination
  • Antihypertensive Agents
Experimental: GROUP B: Valsartan
GROUP B: Treatment with Monotherapy. Valsartan 80 mg. Once daily during 12 weeks.
Drug: 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.
Other Names:
  • Angiotensin II Receptor Antagonist
  • Antihypertensive Agents
Experimental: GROUP C: Chlorthalidone
GROUP C: Treatment with Monotherapy. Chlorthalidone 12,5 mg. Once daily during 12 weeks.
Drug: 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.
Other Names:
  • Sodium Chloride Symporter Inhibitors
  • Antihypertensive Agents
  • Diuretics

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01850160

Locations
Colombia
Centro de Diagnostico Cardiologico Recruiting
Cartagena, Bolivar, Colombia, 130001
Contact: Fernando Manzur Jattin, MD    (057) 5 6652290    coordinacion.cdc@hotmail.com   
Principal Investigator: Fernando Manzur Jattin, MD         
Sub-Investigator: Luz E Cohen, MD         
Fundacion Cardiomet Cequin Recruiting
Armenia, Quindio, Colombia, 630001
Contact: Gregorio Sanchez Vallejo, MD    (057) 7 8872600    marthaadriana14@hotmail.com   
Principal Investigator: Gregorio Sanchez Vallejo, MD         
Sub-Investigator: Andres Gallego Orozco, MD         
MedPlus Recruiting
Bogota DC, Colombia, 11001
Contact: Andres E Rico, MD    (057) 1 5226772    andresr@medplus.com.co   
Principal Investigator: Andres E Rico, MD         
Sub-Investigator: Juan C Chavez, MD         
Ecuador
Clínica DAME Recruiting
Quito, Ecuador, EC170150
Contact: Mayra D Sanchez, MD    0996026583    mayraisanzvelez@hotmail.com   
Principal Investigator: Mayra D Sanchez, MD         
Consultorio Edificio Novoa Recruiting
Quito, Ecuador, EC170150
Contact: Luis F Sanchez, MD    0999738520    lsanchez@pi.pro.ec   
Principal Investigator: Luis F Sanchez, MD         
Centro médico de hipertensión arterial Recruiting
Quito, Ecuador, EC170150
Contact: Diego F Benitez, MD    0992563809    dbenitezapata@hotmail.com   
Principal Investigator: Diego F Benitez, MD         
Centro AMCOR Recruiting
Quito, Ecuador, EC170150
Contact: Ivan A Zuleta, MD    0998313865    ivanzuleta2001@yahoo.es   
Principal Investigator: Ivan A Zuleta, MD         
Centro Clinico quirurgico Recruiting
Quito, Ecuador, EC170150
Contact: Carlos R Chacon, MD    0999663583    cardioanalisis@gmail.com   
Principal Investigator: Carlos R Chacon, MD         
Sponsors and Collaborators
Farma de Colombia SA
Investigators
Study Director: Juan D Romero, MD Farma de Colombia SA
  More Information

No publications provided

Responsible Party: Farma de Colombia SA
ClinicalTrials.gov Identifier: NCT01850160     History of Changes
Other Study ID Numbers: 005-12 HTA
Study First Received: May 7, 2013
Last Updated: May 9, 2013
Health Authority: Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Ecuador: Public Health Ministry

Keywords provided by Farma de Colombia SA:
Hypertension
High blood pressure
Drug therapy combination
Valsartan
Chlorthalidone
Safety
Efficacy

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Valsartan
Antihypertensive Agents
Chlorthalidone
Angiotensin Receptor Antagonists
Sodium Chloride Symporter Inhibitors
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Angiotensin II Type 1 Receptor Blockers
Molecular Mechanisms of Pharmacological Action
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Membrane Transport Modulators

ClinicalTrials.gov processed this record on September 18, 2014