Prospective, Non-interventional Study for the Recording of Adherence to Treatment With Perindopril/Indapamide/Amlodipine Fixed Dose Combination, in a Greek Population With Hypertension

Servier Hellas Pharmaceuticals Ltd.1 site in 1 country2,285 target enrollmentNovember 25, 2015

ConditionsAdherence to Medication Regime Hypertensive Disease

DrugsPerindopril/Indapamide/Amlodipine fixed dose combination

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Adherence to Medication Regime
Sponsor: Servier Hellas Pharmaceuticals Ltd.
Enrollment: 2285
Locations: 1
Primary Endpoint: Adherence to treatment
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The main objective of this study is to record, in routine clinical practice, patients' adherence to treatment with Perindopril/Indapamide/Amlodipine fixed dose combination, during 4 months treatment.

Detailed Description

This is a non-interventional study aiming to record adherence to treatment with Perindopril/Indapamide/Amlodipine fixed dose combination. In parallel blood pressure levels will be recorded, as well as safety and tolerability of this fixed dose combination.

Registry

clinicaltrials.gov

Start Date

November 25, 2015

End Date

December 21, 2016

Last Updated

9 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Servier Hellas Pharmaceuticals Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female, ambulatory patients \>18 years old.
•Clinically diagnosed essential arterial hypertension.
•Under treatment with Perindoril/Indapamide/Amlodipine fixed dose combination.
•The patient has given his/her written consent after being informed, before his inclusion in the study.

Exclusion Criteria

•Secondary arterial hypertension.
•Serious end stage diseases, severe neuropsychiatric diseases, cerebrovascular event with serious residual lesions, scheduled procedure or surgical operation or hospital admission.
•Pregnancy, lactation or intention to become pregnant.

Outcomes

Primary Outcomes

Adherence to treatment

Time Frame: Change of total score of compliance scale between baseline and 1st month and between 1st and 4th month of treatment

Total score of Hill-Bone High Blood Pressure Compliance Scale will be recorded at each study visit

Secondary Outcomes

Diastolic Blood Pressure(All visits (baseline, 1st and 4th month of treatment))
Systolic Blood Pressure(All visits (baseline, 1st and 4th month of treatment))
Adverse events recording leading to treatment discontinuation(1st and 4th month of treatment)