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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02655029
Acronym
CONTROL-3
Enrollment
2285
Registered
2016-01-13
Start date
2015-11-25
Completion date
2016-12-21
Last updated
2017-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adherence to Medication Regime, Hypertensive Disease

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.

Interventions

DRUGPerindopril/Indapamide/Amlodipine fixed dose combination

Dose selection is based on investigators management.

Sponsors

Servier Hellas Pharmaceuticals Ltd.
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Adherence to treatmentChange of total score of compliance scale between baseline and 1st month and between 1st and 4th month of treatmentTotal score of Hill-Bone High Blood Pressure Compliance Scale will be recorded at each study visit

Secondary

MeasureTime frame
Systolic Blood PressureAll visits (baseline, 1st and 4th month of treatment)
Diastolic Blood PressureAll visits (baseline, 1st and 4th month of treatment)
Adverse events recording leading to treatment discontinuation1st and 4th month of treatment

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026