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

January 25, 2016 updated by: Farma de Colombia SA

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

124

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Colombia
      • Bogota DC, Colombia, 11001
        • MedPlus
    • Bolivar
      • Cartagena, Bolivar, Colombia, 130001
        • Centro de Diagnostico Cardiológico
    • Quindio
      • Armenia, Quindio, Colombia, 630001
        • Fundacion Cardiomet Cequin
  • Ecuador
      • Quito, Ecuador, EC170150
        • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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:
  • Antihypertensive Agents
  • Angiotensin II Receptor Antagonist
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:
  • Diuretics
  • Antihypertensive Agents
  • Sodium Chloride Symporter Inhibitors

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 weeks
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
12 weeks
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
12 weeks
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
12 weeks
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
12 weeks
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
12 weeks
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
12 weeks
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
12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks
Incidence of adverse events in each intervention group
Time Frame: 12 weeks
Determine the percentage of incidence of adverse events in each intervention group.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Farma de Colombia SA

Investigators

  • Study Director: Juan D Romero, MD, Farma de Colombia SA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

May 7, 2013

First Submitted That Met QC Criteria

May 7, 2013

First Posted (Estimate)

May 9, 2013

Study Record Updates

Last Update Posted (Estimate)

January 26, 2016

Last Update Submitted That Met QC Criteria

January 25, 2016

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 005-12 HTA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hypertension

Clinical Trials on GROUP A: Valsartan plus Chlorthalidone

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Zambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe