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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GROUP A: Valsartan plus Chlorthalidone | Experimental | GROUP A: Combination therapy of Valsartan plus Chlorthalidone. Valsartan 80 mg/Chlorthalidone 12,5 mg. Once daily during 12 weeks. |
|
| GROUP B: Valsartan | Experimental | GROUP B: Treatment with Monotherapy. Valsartan 80 mg. Once daily during 12 weeks. |
|
| GROUP C: Chlorthalidone | Experimental | GROUP C: Treatment with Monotherapy. Chlorthalidone 12,5 mg. Once daily during 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GROUP A: Valsartan plus Chlorthalidone | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Systolic and Diastolic Blood pressure values | Assess the changes in Systolic and Diastolic Blood Pressure from baseline up to week 12 | 12 weeks |
| Changes of Systolic blood pressure values |
| Measure | Description | Time Frame |
|---|---|---|
| Metabolic changes secondary to the treatment with Valsartan and Chlorthalidone, Vs Valsartan or Chlorthalidone | 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Juan D Romero, MD | Farma de Colombia SA | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MedPlus | Bogota DC | Bogota DC | 11001 | Colombia | ||
| Centro de Diagnostico Cardiologico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30202211 | Derived | 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. |
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|
|
| GROUP B: Valsartan | Drug | 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: Chlorthalidone | Drug | 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. |
|
|
Assess the changes of systolic blood pressure from baseline up to week 6 and 12
| 12 weeks |
| Changes of Diastolic blood pressure values | 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 | 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 | 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 | 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 | 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 | Determine the percentage of patients achieving diastolic blood pressure lower than 90 at week 6 and 12 | 12 weeks |
Determine the percentage of incidence of adverse events in each intervention group. |
| 12 weeks |
| Cartagena |
| Departamento de Bolívar |
| 130001 |
| Colombia |
| Fundacion Cardiomet Cequin | Armenia | Quindío Department | 630001 | Colombia |
| Centro AMCOR | Quito | EC170150 | Ecuador |
| Centro Clinico quirurgico | Quito | EC170150 | Ecuador |
| Centro médico de hipertensión arterial | Quito | EC170150 | Ecuador |
| Clínica DAME | Quito | EC170150 | Ecuador |
| Consultorio Edificio Novoa | Quito | EC170150 | Ecuador |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D002752 | Chlorthalidone |
| D000959 | Antihypertensive Agents |
| D057911 | Angiotensin Receptor Antagonists |
| D049993 | Sodium Chloride Symporter Inhibitors |
| D004232 | Diuretics |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D001577 | Benzophenones |
| D010797 | Phthalimides |
| D007094 | Imides |
| D007659 | Ketones |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D002317 | Cardiovascular Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D049990 | Membrane Transport Modulators |
| D045283 | Natriuretic Agents |
| D045505 | Physiological Effects of Drugs |
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