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

NCT02655029 | Completed

• 1 other identifier: IC4-06593-021-GRC
• Study Type: observational
• Target: 2,285
• Locations: 1 country
• Sites: 1

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.

Conditions

Adherence to Medication Regime; Hypertensive Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Systolic Blood Pressure

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

• Diastolic Blood Pressure

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

• Adverse events recording leading to treatment discontinuation

  1st and 4th month of treatment

Interventions

Perindopril/Indapamide/Amlodipine fixed dose combination DRUG

Dose selection is based on investigators management.

Also known as: Triplixam

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Male or female, ambulatory patients \>18 years old.
• Clinically diagnosed essential arterial hypertension.
• Under treatment with Perindoril/Indapamide/Amlodipine fixed dose combination.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Servier Hellas Pharmaceuticals Ltd.: lead

Study Sites (1)

Ippokratio University Hospital of Athens

Athens, Greece

Location

MeSH Terms

Conditions

Medication Adherence; Hypertension

Interventions

Perindopril; Indapamide; Amlodipine

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Konstantinos Tsioufis, Professor

  Ippokrateion General Hospital of Athens

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2016
• First Posted: January 13, 2016
• Study Start: November 25, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 21, 2016
• Last Updated: March 24, 2017

Record last verified: 2017-03

Locations

GR (1)