Study for the Recording of Adherence to Treatment With Perindopril/Indapamide/Amlodipine Fixed Dose Combination (CONTROL-3)

March 23, 2017 updated by: Servier Hellas Pharmaceuticals Ltd.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / 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 Type

Observational

Enrollment (Actual)

2285

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Athens, Greece
        • Ippokratio University Hospital of Athens

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Greek patients with arterial hypertension who receive treatment with Perindopril/Indapamide/Amlodipine fixed dose combination.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Servier Hellas Pharmaceuticals Ltd.

Investigators

  • Principal Investigator: Konstantinos Tsioufis, Professor, Ippokrateion General Hospital of Athens

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 25, 2015

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 21, 2016

Study Registration Dates

First Submitted

January 5, 2016

First Submitted That Met QC Criteria

January 11, 2016

First Posted (Estimate)

January 13, 2016

Study Record Updates

Last Update Posted (Actual)

March 24, 2017

Last Update Submitted That Met QC Criteria

March 23, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IC4-06593-021-GRC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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