Adherence to Medication RegimeCONTROL-3NCT02655029
Study for the Recording of Adherence to Treatment With Perindopril/Indapamide/Amlodipine Fixed Dose Combination
An observational study of Adherence to Medication Regime and Hypertensive Disease, run by Servier Hellas Pharmaceuticals Ltd. at 1 site in Greece.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adherence to Medication Regime, Hypertensive Disease
- What is being tested?
- Perindopril/Indapamide/Amlodipine fixed dose combination
- How many people
- 2,285 participants
- Where
- 1 siteGreece
- Study dates
- 25 Nov 2015to 21 Dec 2016
- How long will I take part?
- 4 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Greek patients with arterial hypertension who receive treatment with Perindopril/Indapamide/Amlodipine fixed dose combination.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Being tested
- Perindopril/Indapamide/Amlodipine fixed dose combination
- Medical subject headings
- Medication Adherence, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perindopril/Indapamide/Amlodipine fixed dose combinationDrug
Also called Triplixam
Dose selection is based on investigators management.
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to treatment
Total score of Hill-Bone High Blood Pressure Compliance Scale will be recorded at each study visit
Measured: 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
Measured: All visits (baseline, 1st and 4th month of treatment)
Diastolic Blood Pressure
Measured: All visits (baseline, 1st and 4th month of treatment)
Adverse events recording leading to treatment discontinuation
Measured: 1st and 4th month of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2016 (estimated)
- Study start25 Nov 2015
- Primary completionDec 2016
- Study completion21 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adherence to Medication RegimeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,285 participants (actual)
- Target duration
- 4 Months
Sponsor and investigators
- Lead sponsor
- Servier Hellas Pharmaceuticals Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Konstantinos Tsioufis, Professor, Principal investigator, Ippokrateion General Hospital of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02655029
- Sponsor's protocol ID
- IC4-06593-021-GRC
- Acronym
- CONTROL-3
- Status last verified
- Mar 2017
- First submitted
- 5 Jan 2016
- Last updated
- 24 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02655029
- Acronym / sponsor ID
- CONTROL-3 / IC4-06593-021-GRC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,285 participants (actual)
- Lead sponsor
- Servier Hellas Pharmaceuticals Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Nov 2015 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- 21 Dec 2016 (actual)
- First posted
- 13 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Greek patients with arterial hypertension who receive treatment with Perindopril/Indapamide/Amlodipine fixed dose combination.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Perindopril/Indapamide/Amlodipine fixed dose combinationAlso: TriplixamDose selection is based on investigators management. | Drug | – |
Primary outcome
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
3 secondary outcomes
Systolic Blood Pressure
Time frame: All visits (baseline, 1st and 4th month of treatment)
Diastolic Blood Pressure
Time frame: All visits (baseline, 1st and 4th month of treatment)
Adverse events recording leading to treatment discontinuation
Time frame: 1st and 4th month of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2017.
Related trials for Adherence to Medication Regime
Not yet recruiting
Use and Acceptability of an AI-Assisted Health Application for Individuals Living With a Chronic Condition
Hypertension, Diabetes Mellitus, Type 2
Not yet recruiting
A Nurse-Led Personalized Self-Management Counseling Intervention to Improve Medication Adherence and Glycemic Control in Adults With Type 2 Diabetes: A Randomized Controlled Trial
Medication Adherence, Glycemic Control for Diabetes Mellitus
Not yet recruiting
Assessing Psoriasis Treatment Outcomes
Psoriasis
Active, not recruiting
HERDA: Pharmacist-Led Culturally Adapted Intervention for Depression Medication Adherence
Depression
Not yet recruiting
Asthma Ctrl SMART Trial
Asthma in Children, Asthma Chronic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Konstantinos Tsioufis, Professor principal investigator
Ippokrateion General Hospital of Athens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adherence to Medication Regime and Hypertensive Disease, run by Servier Hellas Pharmaceuticals Ltd. at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2017.