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

Condition(s) targeted: Hypertension

Intervention: Indapamide / Losartan (Drug); Indapamide / Losartan (Drug); Indapamide (Drug)

Phase: Phase 3

Status: Not yet recruiting

Sponsored by: EMS

Official(s) and/or principal investigator(s):
Otávio Berwanger, MD, Principal Investigator, Affiliation: Associação do Sanatório Sírio Hosp. do Coração
Luiz C. Bodanese, MD, Principal Investigator, Affiliation: União Brasileira de Educação e Assistência / Hospital São Lucas da PUCRS
José V. Martin, MD, Principal Investigator, Affiliation: Hospital de Base de São José do Rio Preto
Estêvão L. Figueiredo, MD, Principal Investigator, Affiliation: Lifecenter Hospital
Renato D. Lopes, M.D, Principal Investigator, Affiliation: Federal University of São Paulo
Celso Amodeo, M.D., Principal Investigator, Affiliation: Instituto Dante Pazzanese de Cardiologia IDPC São Paulo

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.

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

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

Primary outcome: Changes in systemic blood pressure measurements during 12 weeks

Secondary outcome:

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).

Percentage (%) of patients excluded from the study because of treatment failure

Time to appropriate control of systolic blood pressure and diastolic blood pressure (BP <140/90 mmHg.

Incidence of any adverse events;

Incidence of hypotension

Incidence of serious adverse events and unexpected drug reactions

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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;

Starting date: January 2014
Last updated: August 20, 2013