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
  Purpose

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 Intervention Phase
Hypertension
Drug: Indapamide / Losartan
Drug: Indapamide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by EMS:

Primary Outcome Measures:
  • Changes in systemic blood pressure measurements during 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 255
Study Start Date: January 2014
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Indapamide 1.5mg / Losartan 50mg + Indapamide placebo Drug: Indapamide / Losartan
1 tablet of Indapamide 1.5mg + Losartan 50mg and 1 tablet of Indapamide placebo, a day
Experimental: Indapamide 1.5mg / Losartan 100mg + Indapamide placebo Drug: Indapamide / Losartan
1 tablet of Indapamide1.5mg + Losartan 100mg and 1 tablet of Indapamide placebo, a day
Active Comparator: Indapamide 1.5mg + Indapamide/Losartan placebo Drug: Indapamide
1 tablet of Indapamide 1.5mg and 1 tablet of Indapamide+Losartan placebo, a day

Detailed Description:
  • 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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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;
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01620788

Sponsors and Collaborators
EMS
Investigators
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
  More Information

No publications provided

Responsible Party: EMS
ClinicalTrials.gov Identifier: NCT01620788     History of Changes
Other Study ID Numbers: LIEMS1111
Study First Received: May 29, 2012
Last Updated: August 20, 2013
Health Authority: Brazil: National Health Surveillance Agency

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Indapamide
Losartan
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 23, 2014