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Fixed Combination for Lipid and Blood Pressure Control (FILIP)

Primary Purpose

Arterial Hypertension, Dyslipidemias, Blood Pressure

Status
Withdrawn
Phase
Phase 4
Locations
Czechia
Study Type
Interventional
Intervention
Atorvastatin, Amlodipine, Perindopril
Sponsored by
Charles University, Czech Republic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arterial Hypertension focused on measuring Arterial hypertension, Dyslipidemia, Blood pressure control, Fixed combination

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Center for Cardiovascular Prevention, Charles University Medical Faculty and Thomayer Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Free combination

Fixed combination

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Blood pressure control
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.
Lipids control
To compare the effect of fixed and free combination of atorvastatin/perindopril/amlodipine on LDL cholesterol levels over the 16 weeks follow up.

Secondary Outcome Measures

Adherence
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.
Blood pressure variability
To compare the effect of fixed and free combination of atorvastatin/perindopril/amlodipine on 24h blood pressure variability over the 16 weeks follow up.
Arterial properties
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.

Full Information

First Posted
February 7, 2017
Last Updated
June 19, 2019
Sponsor
Charles University, Czech Republic
Collaborators
University Hospital Olomouc, University Hospital Pilsen, General Teaching Hospital, Prague, St. Anne, Brno University Hospital, Na Homolce Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03047538
Brief Title
Fixed Combination for Lipid and Blood Pressure Control
Acronym
FILIP
Official Title
Fixed Combination for Lipid and Blood Pressure Control. Randomized Cross-over Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Insufficient funds
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charles University, Czech Republic
Collaborators
University Hospital Olomouc, University Hospital Pilsen, General Teaching Hospital, Prague, St. Anne, Brno University Hospital, Na Homolce Hospital

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arterial Hypertension, Dyslipidemias, Blood Pressure, Lipid Metabolism Disorders
Keywords
Arterial hypertension, Dyslipidemia, Blood pressure control, Fixed combination

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Free combination
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Fixed combination
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Atorvastatin, Amlodipine, Perindopril
Intervention Description
To compare free and fixed combination of atorvastatin, perindopril, amlodipine
Primary Outcome Measure Information:
Title
Blood pressure control
Description
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.
Time Frame
16 weeks - 8 weeks fixed and 8 weeks free combination atorvastatin, perindopril, amlodipine
Title
Lipids control
Description
To compare the effect of fixed and free combination of atorvastatin/perindopril/amlodipine on LDL cholesterol levels over the 16 weeks follow up.
Time Frame
16 weeks - 8 weeks fixed and 8 weeks free combination atorvastatin, perindopril, amlodipine
Secondary Outcome Measure Information:
Title
Adherence
Description
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.
Time Frame
16 weeks - 8 weeks fixed and 8 weeks free combination atorvastatin, perindopril, amlodipine
Title
Blood pressure variability
Description
To compare the effect of fixed and free combination of atorvastatin/perindopril/amlodipine on 24h blood pressure variability over the 16 weeks follow up.
Time Frame
16 weeks - 8 weeks fixed and 8 weeks free combination atorvastatin, perindopril, amlodipine
Title
Arterial properties
Description
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.
Time Frame
16 weeks - 8 weeks fixed and 8 weeks free combination atorvastatin, perindopril, amlodipine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: a very high cardiovascular risk and LDL-cholesterol> 1.8 mmol / l a high cardiovascular risk and LDL-cholesterol> 2.5 mmol / l Patient with a high or very high cardiovascular risk treated by lipidlowering therapy with statin Exclusion Criteria: hypersensitivity to perindopril or to other ACE inhibitors, amlodipine, atorvastatin, dihydropyridines or to or statins angioneurotic edema in medical history (hereditary / idiopathic or associated with prior treatment with ACE inhibitors) severe hypotension, shock, including cardiogenic shock hemodynamically unstable heart failure Active liver disease or unexplained persistent elevations of serum transaminases more than three times normal Women of childbearing age without reliable contraception pregnancy breastfeeding Patients with contraindications listed in the currently valid SP
Facility Information:
Facility Name
Center for Cardiovascular Prevention, Charles University Medical Faculty and Thomayer Hospital
City
Prague
ZIP/Postal Code
140 59
Country
Czechia

12. IPD Sharing Statement

Plan to Share IPD
No
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Fixed Combination for Lipid and Blood Pressure Control

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