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Comparison of Losartan Associated With Indapamide Versus Hyzaar® in the Hypertension Treatment

This study is not yet open for participant recruitment.
Verified January 2017 by EMS
Sponsor:
ClinicalTrials.gov Identifier:
NCT01620788
First Posted: June 15, 2012
Last Update Posted: January 27, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
EMS
May 29, 2012
June 15, 2012
January 27, 2017
May 2017
December 2017   (Final data collection date for primary outcome measure)
Changes in systemic blood pressure measurements during 12 weeks [ Time Frame: 12 weeks ]
Same as current
Complete list of historical versions of study NCT01620788 on ClinicalTrials.gov Archive Site
Safety Will be Evaluated by the Adverse Events Occurrences [ Time Frame: 12 weeks ]
  • Changes in systolic blood pressure measurements during 12 weeks [ Time Frame: 12 weeks ]
  • Changes in diastolic blood pressure measurements during 12 weeks [ Time Frame: 12 weeks ]
  • Assessment of safety parameters defined by the protocol (hematology, liver function, renal function); [ Time Frame: 12 weeks ]
  • Incidence of any adverse events; [ Time Frame: 12 weeks ]
  • Incidence of hypotension [ Time Frame: 12 weeks ]
  • Incidence of serious adverse events and unexpected drug reactions [ Time Frame: 12 weeks ]
Not Provided
Not Provided
 
Comparison of Losartan Associated With Indapamide Versus Hyzaar® in the Hypertension Treatment
Randomized, Phase 3, Multicenter, Open Label, Evaluating the Effect of the Treatment of Indapamide 1.5mg/Losartan 50mg and Indapamide 1.5mg/Losartan 100mg, Compared With Hyzaar® in the Treatment of Hypertension
The purpose of this study is to evaluate the clinical efficacy of indapamide 1.5mg / losartan 50mg and indapamide 1.5mg / losartan 100mg on reduction of blood pressure.
  • open label,randomized, multicenter
  • Experiment duration: 12 weeks.
  • 05 visits (day 0 - randomization), (day 1 - 2 weeks pos-randomization), (day 2 - 4 weeks pos-randomization), (day 3 - 8 weeks pos-randomization) and (day 4 - 12 weeks pos-randomization).
  • evaluate the efficacy of a medication associated with two antihypertensive agents in two fixed doses compared to the Hyzaar® in patients with hypertension
  • Adverse events evaluation
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Hypertension
  • Drug: Indapamide / Losartan
    1 tablet of Indapamide 1.5mg + Losartan 50mg, oral, a day
    Other Name: Indapamide 1.5mg / Losartan 50mg
  • Drug: Indapamide / Losartan
    1 tablet of Indapamide 1.5mg + Losartan 100mg, oral, a day
    Other Name: Indapamide 1.5mg / Losartan 100mg
  • Drug: Hyzaar®
    1 tablet of Hyzaar®, oral, a day
    Other Name: Losartan 50mg/Hydrochlorothiazide12,5mg
  • Drug: Hyzaar®
    1 tablet of Hyzaar®, oral, a day
    Other Name: Losartan 100mg/Hydrochlorothiazide 25mg
  • Experimental: Indapamide 1.5mg / Losartan 50mg
    Intervention: Drug: Indapamide / Losartan
  • Experimental: Indapamide 1.5mg / Losartan 100mg
    Intervention: Drug: Indapamide / Losartan
  • Active Comparator: Hyzaar® (Losartan 50mg/Hydrochlorothiazide12,5mg)
    Intervention: Drug: Hyzaar®
  • Active Comparator: Hyzaar® (Losartan 100mg/Hydrochlorothiazide 25mg)
    Intervention: Drug: Hyzaar®
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
636
March 2018
December 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adults male or female aged ≥ 18 years old;
  • Patients with a diagnosis of Hypertension (defined by the medical investigator) treated with monotherapy or at least two blood pressure measurements ≥ 140/90, in a sitting position with a 5' interval between measurements,
  • Patients with normal lab tests results in the last six months or that the investigator consider not clinically significant,
  • Patient who accept the discontinuation of previous hypertension therapy.

Exclusion Criteria:

  • Patients with blood pressure ≥ 180/100 mmHg;
  • Patients with uncontrolled hypertension (≥ 140/90 mmHg) treated with thiazide diuretics;
  • Presence of concomitant coronary artery disease, congestive heart failure, diabetes and renal failure (creatinine> 1.5 mg / dL);
  • Patients with hypo or hyperkalemia (serum potassium outside normal range);
  • Patients with ALT greater than 2.5 the upper limit of normal or active liver disease;
  • Pregnant women, or women in childbearing age who are not in use effective contraception or intending to become pregnant during the study period;
  • Patients on drug or alcohol abuse in the last two years;
  • Patients with secondary hypertension (renovascular disease, pheochromocytoma, Cushing's syndrome);
  • Patients with allergic reactions or hypersensitivity to ACE inhibitors, diuretics or medications containing sulfa and / or any excipients of formulation;
  • Refusal or inability to provide the Informed Consent Term.;
  • Refusal to discontinue the anti-hypertensive medication.
  • Patients at the discretion of the investigator does not have indication for discontinuing the current medications;
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Roberto B. Amazonas, MD +551938879851 pesquisa.clinica@ems.com.br
Not Provided
 
 
NCT01620788
LIEMS1111
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
EMS
EMS
Not Provided
Principal Investigator: Otávio Berwanger, MD Associação do Sanatório Sírio Hosp. do Coração
Principal Investigator: Luiz C. Bodanese, MD União Brasileira de Educação e Assistência / Hospital São Lucas da PUCRS
Principal Investigator: José V. Martin, MD Hospital de Base de São José do Rio Preto
Principal Investigator: Estêvão L. Figueiredo, MD Lifecenter Hospital
Principal Investigator: Renato D. Lopes, M.D Federal University of São Paulo
Principal Investigator: Celso Amodeo, M.D. Instituto Dante Pazzanese de Cardiologia IDPC São Paulo
EMS
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP