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HypertensionPhase 3NCT01850160

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

A Phase 3 study testing GROUP A: Valsartan plus Chlorthalidone, GROUP B: Valsartan and GROUP C: Chlorthalidone in people with Hypertension, run by Farma de Colombia SA at 8 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Hypertension
What is being tested?
GROUP A: Valsartan plus Chlorthalidone, GROUP B: Valsartan and GROUP C: Chlorthalidone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
124 participants
Where
8 sitesin 2 countries
Study dates
Apr 2013to May 2015
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 17Show fewer
  • 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.

Trial locations and contacts

8 sites in 2 countries.

8 sites in 2 countries

Ecuador5 sites

  • Centro AMCOR

    Quito, EC170150

  • Centro Clinico quirurgico

    Quito, EC170150

  • Centro médico de hipertensión arterial

    Quito, EC170150

  • Clínica DAME

    Quito, EC170150

  • Consultorio Edificio Novoa

    Quito, EC170150

Other trials in Ecuador

Colombia3 sites

  • Fundacion Cardiomet Cequin

    Armenia, Quindío Department, 630001

  • MedPlus

    Bogota DC, Bogota DC, 11001

  • Centro de Diagnostico Cardiologico

    Cartagena, Departamento de Bolívar, 130001

Other trials in Colombia

About this study

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

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.

Read the 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.

Conditions
Hypertension
Being tested
GROUP A: Valsartan plus Chlorthalidone, GROUP B: Valsartan, GROUP C: Chlorthalidone
Keywords
Hypertension, High blood pressure, Drug therapy combination, Valsartan, Chlorthalidone, Safety, Efficacy
Medical subject headings
Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GROUP A: Valsartan plus ChlorthalidoneDrug

    Also called Chlorthalidone Drug Combination, Valsartan Drug Combination, Antihypertensive Agents

    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.

  • GROUP B: ValsartanDrug

    Also called Angiotensin II Receptor Antagonist, Antihypertensive Agents

    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.

  • GROUP C: ChlorthalidoneDrug

    Also called Sodium Chloride Symporter Inhibitors, Antihypertensive Agents, Diuretics

    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.

Study groups in NCT01850160
Study groupRoleWhat they receive
GROUP A: Valsartan plus ChlorthalidoneExperimentalGROUP A: Combination therapy of Valsartan plus Chlorthalidone. Valsartan 80 mg/Chlorthalidone 12,5 mg. Once daily during 12 weeks.
Receives: Drug: GROUP A: Valsartan plus Chlorthalidone
GROUP B: ValsartanExperimentalGROUP B: Treatment with Monotherapy. Valsartan 80 mg. Once daily during 12 weeks.
Receives: Drug: GROUP B: Valsartan
GROUP C: ChlorthalidoneExperimentalGROUP C: Treatment with Monotherapy. Chlorthalidone 12,5 mg. Once daily during 12 weeks.
Receives: Drug: GROUP C: Chlorthalidone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety and Efficacy of the fixed-dose combination treatment with Valsartan plus Chlorthalidone

    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

    Measured: 12 weeks

Secondary outcomes (8)

  1. Changes in Systolic and Diastolic Blood pressure values

    Assess the changes in Systolic and Diastolic Blood Pressure from baseline up to week 12

    Measured: 12 weeks

  2. Changes of Systolic blood pressure values

    Assess the changes of systolic blood pressure from baseline up to week 6 and 12

    Measured: 12 weeks

  3. Changes of Diastolic blood pressure values

    Assess the changes of diastolic blood pressure from baseline up to week 6 and 12

    Measured: 12 weeks

  4. Changes of diastolic blood pressure in arterial blood pressure median values

    Assess the changes in diastolic blood pressure in Arterial Blood Pressure Media from baseline up to week 12

    Measured: 12 weeks

  5. Changes of systolic blood pressure values in arterial blood pressure median values

    Assess the change in systolic blood pressure in Arterial Blood Pressure Median from baseline up to week 12

    Measured: 12 weeks

  6. Patient that achieving blood pressure values lower than 140/90 (systolic/diastolic) at week 6 and 12

    Determine the percentage of patients achieving blood pressure values lower than 140/90 (systolic/diastolic) at weeks 6 and 12

    Measured: 12 weeks

  7. Patients that achieving systolic blood pressure values lower than 140 at week 6 and 12

    Determine the percentage of patients achieving systolic blood pressure lower than 140 at weeks 6 and 12

    Measured: 12 weeks

  8. Patients that achieving diastolic blood pressure values lower than 90 at week 6 and 12

    Determine the percentage of patients achieving diastolic blood pressure lower than 90 at week 6 and 12

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 May 2013 (estimated)
  2. Study startApr 2013
  3. Primary completionMar 2015
  4. Study completionMay 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
124 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01850160
Sponsor's protocol ID
005-12 HTA
Status last verified
Mar 2015
First submitted
7 May 2013
Last updated
26 Jan 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Manzur F, Rico A, Romero JD, Rodriguez-Martinez CE. Efficacy and Safety of Valsartan or Chlorthalidone vs. Combined Valsartan and Chlorthalidone in Patients With Mild to Moderate Hypertension: The VACLOR Study. Clin Med Insights Cardiol. 2018 Sep 3;12:1179546818796482. doi: 10.1177/1179546818796482. eCollection 2018.

    PubMed 30202211

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing GROUP A: Valsartan plus Chlorthalidone, GROUP B: Valsartan and GROUP C: Chlorthalidone in people with Hypertension, run by Farma de Colombia SA at 8 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Ecuador, Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and Efficacy of the fixed-dose combination treatment with Valsartan plus Chlorthalidone (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01850160, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2016.

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