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

This study is not yet open for participant recruitment. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Arrhythmia Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on September 11, 2014