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OpenTrials
Completed

NCT Number: NCT02655029

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

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.

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Key information

Conditions

Adherence to Medication Regime Behavior Cardiovascular Diseases Health Behavior Hypertension Hypertensive Disease Medication Adherence Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ippokratio University Hospital of Athens

Athens, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Perindopril/Indapamide/Amlodipine fixed dose combination

Drug

Dose selection is based on investigators management.

Other names: Triplixam

Primary outcomes

  1. 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

  1. Systolic Blood Pressure

    Time frame: All visits (baseline, 1st and 4th month of treatment)

  2. Diastolic Blood Pressure

    Time frame: All visits (baseline, 1st and 4th month of treatment)

  3. Adverse events recording leading to treatment discontinuation

    Time frame: 1st and 4th month of treatment

Sponsors and collaborators

Lead sponsor

Servier Hellas Pharmaceuticals Ltd.

Industry

Registry information

Official study title

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

Acronym: CONTROL-3

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jan 13, 2016
Registry last updated
Mar 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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