NCT01620788

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.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
636

participants targeted

Target at P50-P75 for phase_3 hypertension

Timeline
Completed

Started Nov 2019

Longer than P75 for phase_3 hypertension

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 29, 2012

Completed
17 days until next milestone

First Posted

Study publicly available on registry

June 15, 2012

Completed
7.5 years until next milestone

Study Start

First participant enrolled

November 27, 2019

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

July 27, 2022

Status Verified

July 1, 2022

Enrollment Period

3.6 years

First QC Date

May 29, 2012

Last Update Submit

July 25, 2022

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

  • Changes in systemic blood pressure measurements after 12 weeks

    12 weeks

Secondary Outcomes (1)

  • Safety Will be Evaluated by the Adverse Events Occurrences

    12 weeks

Study Arms (4)

Indapamide 1.5mg / Losartan 50mg

EXPERIMENTAL
Drug: Indapamide / Losartan

Indapamide 1.5mg / Losartan 100mg

EXPERIMENTAL
Drug: Indapamide / Losartan

Hyzaar® (Losartan 50mg/Hydrochlorothiazide12,5mg)

ACTIVE COMPARATOR
Drug: Hyzaar®

Hyzaar® (Losartan 100mg/Hydrochlorothiazide 25mg)

ACTIVE COMPARATOR
Drug: Hyzaar®

Interventions

Indapamide / LosartanDRUG

1 tablet of Indapamide 1.5mg + Losartan 50mg, oral, a day

Also known as: Indapamide 1.5mg / Losartan 50mg
Indapamide 1.5mg / Losartan 50mg
Hyzaar®DRUG

1 tablet of Hyzaar®, oral, a day

Also known as: Losartan 50mg/Hydrochlorothiazide12,5mg
Hyzaar® (Losartan 50mg/Hydrochlorothiazide12,5mg)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Allergisa

Campinas, São Paulo, Brazil

Location

MeSH Terms

Conditions

Hypertension

Interventions

IndapamideLosartanhydrochlorothiazide, losartan drug combinationHydrochlorothiazide

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsSulfonesSulfur CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsBiphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsImidazolesAzolesHeterocyclic Compounds, 1-RingTetrazolesChlorothiazideBenzothiadiazinesThiazides

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2012

First Posted

June 15, 2012

Study Start

November 27, 2019

Primary Completion

July 1, 2023

Study Completion

October 1, 2023

Last Updated

July 27, 2022

Record last verified: 2022-07

Locations

BR(1)