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

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. Identifier: NCT01620788
Recruitment Status : Not yet recruiting
First Posted : June 15, 2012
Last Update Posted : January 5, 2018
Information provided by (Responsible Party):

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Indapamide / Losartan Drug: Hyzaar® Phase 3

Detailed Description:
  • 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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 636 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Anticipated Study Start Date : September 2018
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Indapamide 1.5mg / Losartan 50mg Drug: Indapamide / Losartan
1 tablet of Indapamide 1.5mg + Losartan 50mg, oral, a day
Other Name: Indapamide 1.5mg / Losartan 50mg
Experimental: Indapamide 1.5mg / Losartan 100mg Drug: Indapamide / Losartan
1 tablet of Indapamide 1.5mg + Losartan 100mg, oral, a day
Other Name: Indapamide 1.5mg / Losartan 100mg
Active Comparator: Hyzaar® (Losartan 50mg/Hydrochlorothiazide12,5mg) Drug: Hyzaar®
1 tablet of Hyzaar®, oral, a day
Other Name: Losartan 50mg/Hydrochlorothiazide12,5mg
Active Comparator: Hyzaar® (Losartan 100mg/Hydrochlorothiazide 25mg) Drug: Hyzaar®
1 tablet of Hyzaar®, oral, a day
Other Name: Losartan 100mg/Hydrochlorothiazide 25mg

Primary Outcome Measures :
  1. Changes in systemic blood pressure measurements after 12 weeks [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Safety Will be Evaluated by the Adverse Events Occurrences [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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;

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 identifier (NCT number): NCT01620788

Contact: Roberto B. Amazonas, MD +551938879851

Sponsors and Collaborators
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

Responsible Party: EMS Identifier: NCT01620788     History of Changes
Other Study ID Numbers: LIEMS1111
First Posted: June 15, 2012    Key Record Dates
Last Update Posted: January 5, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Anti-Arrhythmia Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators