Fixed Combination for Lipid and Blood Pressure Control

Phase 4

Withdrawn

• Conditions: Dyslipidemias; Arterial Hypertension; Lipid Metabolism Disorders; Blood Pressure
• Interventions: Drug: Atorvastatin, Amlodipine, Perindopril

• Registration Number: NCT03047538
• Lead Sponsor: Charles University, Czech Republic

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-02-07
• Study First Submitted QC: 2017-02-08
• Study First Posted: 2017-02-09
• Study Start: 2017-09-01
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-19
• Last Update Posted: 2019-06-21
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Free combination	Atorvastatin, Amlodipine, Perindopril	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	Atorvastatin, Amlodipine, Perindopril	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.

Primary Outcome Measures

Name	Time	Method
Blood pressure control	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.
Lipids control	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.

Secondary Outcome Measures

Name	Time	Method
Adherence	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.
Blood pressure variability	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.
Arterial properties	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.

Trial Locations

Locations (1)

Center for Cardiovascular Prevention, Charles University Medical Faculty and Thomayer Hospital; 🇨🇿 Prague, Czechia