Fixed Combination for Lipid and Blood Pressure Control (FILIP)

June 19, 2019 updated by: Peter Wohlfahrt, Charles University, Czech Republic

Fixed Combination for Lipid and Blood Pressure Control. Randomized Cross-over Study

The aim of this study is to compare the effect of fixed and free combination of atorvastatin/perindopril/amlodipine on blood pressure and lipid levels.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

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

  • Czechia
      • Prague, Czechia, 140 59
        • Center for Cardiovascular Prevention, Charles University Medical Faculty and Thomayer Hospital

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

Description

Inclusion Criteria:

Patients with uncontrolled arterial hypertension (the average 24h blood pressure in the range 130/80 - 180/110 mmHg and / or daytime average blood pressure in the range 135/85-180/110 mmHg) and one of the following:

  1. a very high cardiovascular risk and LDL-cholesterol> 1.8 mmol / l
  2. a high cardiovascular risk and LDL-cholesterol> 2.5 mmol / l
  3. Patient with a high or very high cardiovascular risk treated by lipidlowering therapy with statin

Exclusion Criteria:

  1. hypersensitivity to perindopril or to other ACE inhibitors, amlodipine, atorvastatin, dihydropyridines or to or statins
  2. angioneurotic edema in medical history (hereditary / idiopathic or associated with prior treatment with ACE inhibitors)
  3. severe hypotension, shock, including cardiogenic shock
  4. hemodynamically unstable heart failure
  5. Active liver disease or unexplained persistent elevations of serum transaminases more than three times normal
  6. Women of childbearing age without reliable contraception
  7. pregnancy
  8. breastfeeding
  9. Patients with contraindications listed in the currently valid SP

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Free combination
Free combination of atorvastatin, perindopril and amlodipine will be given for 8 weeks. After 8 weeks free combination will be changed to fixed combination. The dose of each drug will be selected according to clinical judgement of each investigator, but can not be changed during the coarse of the study.
Drug: Atorvastatin, Amlodipine, Perindopril
To compare free and fixed combination of atorvastatin, perindopril, amlodipine
Active Comparator: Fixed combination
Fixed combination of atorvastatin, perindopril and amlodipine will be given for 8 weeks. After 8 weeks fixed combination will be changed to free combination. The dose of each drug will be selected according to clinical judgement of each investigator, but can not be changed during the coarse of the study.
Drug: Atorvastatin, Amlodipine, Perindopril
To compare free and fixed combination of atorvastatin, perindopril, amlodipine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood pressure control
Time Frame: 16 weeks - 8 weeks fixed and 8 weeks free combination atorvastatin, perindopril, amlodipine
To compare the effect of fixed and free combination of atorvastatin/perindopril/amlodipine on 24h and in clinic blood pressure over the 16 weeks follow up.
16 weeks - 8 weeks fixed and 8 weeks free combination atorvastatin, perindopril, amlodipine
Lipids control
Time Frame: 16 weeks - 8 weeks fixed and 8 weeks free combination atorvastatin, perindopril, amlodipine
To compare the effect of fixed and free combination of atorvastatin/perindopril/amlodipine on LDL cholesterol levels over the 16 weeks follow up.
16 weeks - 8 weeks fixed and 8 weeks free combination atorvastatin, perindopril, amlodipine

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence
Time Frame: 16 weeks - 8 weeks fixed and 8 weeks free combination atorvastatin, perindopril, amlodipine
1. To compare the effect of fixed and free combination of atorvastatin/perindopril/amlodipine on adherence evaluated by the Morisky medication adherence scale 8 and tablet counting over the 16 weeks follow up.
16 weeks - 8 weeks fixed and 8 weeks free combination atorvastatin, perindopril, amlodipine
Blood pressure variability
Time Frame: 16 weeks - 8 weeks fixed and 8 weeks free combination atorvastatin, perindopril, amlodipine
To compare the effect of fixed and free combination of atorvastatin/perindopril/amlodipine on 24h blood pressure variability over the 16 weeks follow up.
16 weeks - 8 weeks fixed and 8 weeks free combination atorvastatin, perindopril, amlodipine
Arterial properties
Time Frame: 16 weeks - 8 weeks fixed and 8 weeks free combination atorvastatin, perindopril, amlodipine
o compare the effect of fixed and free combination of atorvastatin/perindopril/amlodipine on arterial properties and central hemodynamic parameters measured during the 24 monitoring by the Mobilograph device over the 16 weeks follow up.
16 weeks - 8 weeks fixed and 8 weeks free combination atorvastatin, perindopril, amlodipine

Collaborators and Investigators

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

Sponsor

Charles University, Czech Republic

Collaborators

Brno University Hospital
University Hospital Olomouc
University Hospital Pilsen
St. Anne
Na Homolce Hospital
General Teaching Hospital, Prague

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

September 1, 2017

Primary Completion (Anticipated)

December 31, 2019

Study Completion (Anticipated)

December 31, 2019

Study Registration Dates

First Submitted

February 7, 2017

First Submitted That Met QC Criteria

February 8, 2017

First Posted (Estimate)

February 9, 2017

Study Record Updates

Last Update Posted (Actual)

June 21, 2019

Last Update Submitted That Met QC Criteria

June 19, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FILIP_V1.2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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