Fixed Combination for Lipid and Blood Pressure Control (FILIP)

Charles University, Czech Republic

Status and phase: Withdrawn; Phase 4

Conditions: Lipid Metabolism Disorders; Dyslipidemias; Arterial Hypertension; Blood Pressure

Treatments: Drug: Atorvastatin, Amlodipine, Perindopril

Study type: Interventional

Funder types: Other

Identifiers

NCT03047538

FILIP_V1.2

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Free combination

Active Comparator group

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.

Treatment:

Drug: Atorvastatin, Amlodipine, Perindopril

Fixed combination

Active Comparator group

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.

Treatment:

Drug: Atorvastatin, Amlodipine, Perindopril