Study for the Recording of Adherence to Treatment With Perindopril/Indapamide/Amlodipine Fixed Dose Combination

Completed

• Conditions: Adherence to Medication Regime; Hypertensive Disease

• Registration Number: NCT02655029
• Lead Sponsor: Servier Hellas Pharmaceuticals Ltd.

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.

Study Timeline

• Study Start: 2015-11-25
• Study First Submitted: 2016-01-05
• Study First Submitted QC: 2016-01-11
• Study First Posted: 2016-01-13
• Primary Completion: 2016-12
• Study Completion: 2016-12-21
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-23
• Last Update Posted: 2017-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2285

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adherence to treatment	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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Ippokratio University Hospital of Athens; 🇬🇷 Athens, Greece