Overview

Fixed Combination for Lipid and Blood Pressure Control

Status:
Withdrawn

Trial end date:
2019-12-31

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Charles University, Czech Republic

Collaborators:

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

Treatments:

Amlodipine
Atorvastatin
Atorvastatin Calcium
Perindopril

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:

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