We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01850160
Recruitment Status : Completed
First Posted : May 9, 2013
Last Update Posted : January 26, 2016
Sponsor:
Information provided by (Responsible Party):
Farma de Colombia SA

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 diagnosis of arterial hypertension.

Condition or disease Intervention/treatment Phase
Hypertension Drug: GROUP A: Valsartan plus Chlorthalidone Drug: GROUP B: Valsartan Drug: GROUP C: Chlorthalidone Phase 3

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.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : April 2013
Actual Primary Completion Date : March 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Safety

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Safety and Efficacy of the fixed-dose combination treatment with Valsartan plus Chlorthalidone [ Time Frame: 12 weeks ]
    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 :
  1. Changes in Systolic and Diastolic Blood pressure values [ Time Frame: 12 weeks ]
    Assess the changes in Systolic and Diastolic Blood Pressure from baseline up to week 12

  2. Changes of Systolic blood pressure values [ Time Frame: 12 weeks ]
    Assess the changes of systolic blood pressure from baseline up to week 6 and 12

  3. Changes of Diastolic blood pressure values [ Time Frame: 12 weeks ]
    Assess the changes of diastolic blood pressure from baseline up to week 6 and 12

  4. Changes of diastolic blood pressure in arterial blood pressure median values [ Time Frame: 12 weeks ]
    Assess the changes in diastolic blood pressure in Arterial Blood Pressure Media from baseline up to week 12

  5. Changes of systolic blood pressure values in arterial blood pressure median values [ Time Frame: 12 weeks ]
    Assess the change in systolic blood pressure in Arterial Blood Pressure Median from baseline up to week 12

  6. Patient that achieving blood pressure values lower than 140/90 (systolic/diastolic) at week 6 and 12 [ Time Frame: 12 weeks ]
    Determine the percentage of patients achieving blood pressure values lower than 140/90 (systolic/diastolic) at weeks 6 and 12

  7. Patients that achieving systolic blood pressure values lower than 140 at week 6 and 12 [ Time Frame: 12 weeks ]
    Determine the percentage of patients achieving systolic blood pressure lower than 140 at weeks 6 and 12

  8. Patients that achieving diastolic blood pressure values lower than 90 at week 6 and 12 [ Time Frame: 12 weeks ]
    Determine the percentage of patients achieving diastolic blood pressure lower than 90 at week 6 and 12


Other Outcome Measures:
  1. Metabolic changes secondary to the treatment with Valsartan and Chlorthalidone, Vs Valsartan or Chlorthalidone [ Time Frame: 12 weeks ]
    Identify if there are significant differences regarding metabolic changes secondary to the treatment with Valsartan and Chlorthalidone Vs Valsartan or Chlorthalidone.

  2. Incidence of adverse events in each intervention group [ Time Frame: 12 weeks ]
    Determine the percentage of incidence of adverse events in each intervention group.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01850160


Locations
Layout table for location information
Colombia
Centro de Diagnostico Cardiologico
Cartagena, Bolivar, Colombia, 130001
Fundacion Cardiomet Cequin
Armenia, Quindio, Colombia, 630001
MedPlus
Bogota DC, Colombia, 11001
Ecuador
Centro AMCOR
Quito, Ecuador, EC170150
Centro Clinico quirurgico
Quito, Ecuador, EC170150
Centro médico de hipertensión arterial
Quito, Ecuador, EC170150
Clínica DAME
Quito, Ecuador, EC170150
Consultorio Edificio Novoa
Quito, Ecuador, EC170150
Sponsors and Collaborators
Farma de Colombia SA
Investigators
Layout table for investigator information
Study Director: Juan D Romero, MD Farma de Colombia SA
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Farma de Colombia SA
ClinicalTrials.gov Identifier: NCT01850160    
Other Study ID Numbers: 005-12 HTA
First Posted: May 9, 2013    Key Record Dates
Last Update Posted: January 26, 2016
Last Verified: March 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Farma de Colombia SA:
Hypertension
High blood pressure
Drug therapy combination
Valsartan
 Chlorthalidone
Safety
Efficacy
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypertension
Vascular Diseases
Cardiovascular Diseases
Valsartan
Antihypertensive Agents
Chlorthalidone
Angiotensin II
Angiotensin Receptor Antagonists
 Diuretics
Sodium Chloride Symporter Inhibitors
Angiotensin II Type 1 Receptor Blockers
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Physiological Effects of Drugs
Membrane Transport Modulators
Vasoconstrictor Agents