Comparison of Losartan Associated With Indapamide Versus Indapamide for Treatment of Hypertension

This study is not yet open for participant recruitment.
Verified August 2013 by EMS
Sponsor:
Information provided by (Responsible Party):
EMS
ClinicalTrials.gov Identifier:
NCT01620788
First received: May 29, 2012
Last updated: August 20, 2013
Last verified: August 2013

May 29, 2012
August 20, 2013
January 2014
June 2014   (final data collection date for primary outcome measure)
Changes in systemic blood pressure measurements during 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01620788 on ClinicalTrials.gov Archive Site
  • Percentage (%) of patients with blood pressure < 140 / 90 mmHg during 12 weeks, will be obtained comparing the differences between initial blood pressure (initial visit) and final (final visit). [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Percentage (%) of patients excluded from the study because of treatment failure [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Time to appropriate control of systolic blood pressure and diastolic blood pressure (BP <140/90 mmHg. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Incidence of any adverse events; [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Incidence of hypotension [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Incidence of serious adverse events and unexpected drug reactions [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Changes in systolic blood pressure measurements during 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Changes in diastolic blood pressure measurements during 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Assessment of safety parameters defined by the protocol (hematology, liver function, renal function); [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Incidence of any adverse events; [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Incidence of hypotension [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Incidence of serious adverse events and unexpected drug reactions [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Comparison of Losartan Associated With Indapamide Versus Indapamide for Treatment of Hypertension
Randomized, Phase 3, Multicenter, Double-blind, Double Dummy, Evaluating the Effect of Combined Treatment of Indapamide 1.5mg/Losartan 50mg and Indapamide 1.5mg/Losartan 100mg, Compared With 1.5 mg Indapamide Monotherapy 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.

  • double-blind,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 monotherapy in patients with hypertension
  • Adverse events evaluation
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Hypertension
  • Drug: Indapamide / Losartan
    1 tablet of Indapamide 1.5mg + Losartan 50mg and 1 tablet of Indapamide placebo, a day
  • Drug: Indapamide / Losartan
    1 tablet of Indapamide1.5mg + Losartan 100mg and 1 tablet of Indapamide placebo, a day
  • Drug: Indapamide
    1 tablet of Indapamide 1.5mg and 1 tablet of Indapamide+Losartan placebo, a day
  • Experimental: Indapamide 1.5mg / Losartan 50mg + Indapamide placebo
    Intervention: Drug: Indapamide / Losartan
  • Experimental: Indapamide 1.5mg / Losartan 100mg + Indapamide placebo
    Intervention: Drug: Indapamide / Losartan
  • Active Comparator: Indapamide 1.5mg + Indapamide/Losartan placebo
    Intervention: Drug: Indapamide
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
255
February 2015
June 2014   (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;
Both
18 Years and older
No
Not Provided
Not Provided
 
NCT01620788
LIEMS1111
Yes
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
August 2013

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