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

Hypertensive Disease Clinical Trial

— CONTROL-3  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02655029
• Other study ID #: IC4-06593-021-GRC
• Status: Completed
• Phase: N/A
• First received: January 5, 2016
• Last updated: March 23, 2017
• Start date: November 25, 2015
• Est. completion date: December 21, 2016

Study information

• Verified date: March 2017
• Source: Servier Hellas Pharmaceuticals Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2285
• Est. completion date: December 21, 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adherence to Medication Regime
• Hypertension
• Hypertensive Disease

Intervention

Drug:
• Perindopril/Indapamide/Amlodipine fixed dose combination
Dose selection is based on investigators management.

Locations

Country	Name	City	State
Greece	Ippokratio University Hospital of Athens	Athens

Sponsors (1)

Lead Sponsor	Collaborator
Servier Hellas Pharmaceuticals Ltd.

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence to 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	Systolic Blood Pressure		All visits (baseline, 1st and 4th month of treatment)
Secondary	Diastolic Blood Pressure		All visits (baseline, 1st and 4th month of treatment)
Secondary	Adverse events recording leading to treatment discontinuation		1st and 4th month of treatment