Clinical trial NCT03047538: Fixed Combination for Lipid and Blood Pressure Control
Official title: Fixed Combination for Lipid and Blood Pressure Control. Randomized Cross-over Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Arterial Hypertension
Dyslipidemias
Blood Pressure
Lipid Metabolism Disorders
Keywords: Arterial hypertension
Dyslipidemia
Blood pressure control
Fixed combination
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
Collaborators: name: University Hospital Olomouc
name: University Hospital Pilsen
name: General Teaching Hospital, Prague
name: St. Anne
name: Brno University Hospital
name: Na Homolce Hospital
First posted: 2017-02-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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:

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

Primary outcomes:
measure: Blood pressure control
timeFrame: 16 weeks - 8 weeks fixed and 8 weeks free combination atorvastatin, perindopril, amlodipine
measure: Lipids control
timeFrame: 16 weeks - 8 weeks fixed and 8 weeks free combination atorvastatin, perindopril, amlodipine
Secondary outcomes:
measure: Adherence
timeFrame: 16 weeks - 8 weeks fixed and 8 weeks free combination atorvastatin, perindopril, amlodipine
measure: Blood pressure variability
timeFrame: 16 weeks - 8 weeks fixed and 8 weeks free combination atorvastatin, perindopril, amlodipine
measure: Arterial properties
timeFrame: 16 weeks - 8 weeks fixed and 8 weeks free combination atorvastatin, perindopril, amlodipine
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: Center for Cardiovascular Prevention, Charles University Medical Faculty and Thomayer Hospital
Study officials:
References:
citation: Lawes CM, Vander Hoorn S, Rodgers A; International Society of Hypertension. Global burden of blood-pressure-related disease, 2001. Lancet. 2008 May 3;371(9623):1513-8. doi: 10.1016/S0140-6736(08)60655-8.
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citation: Neutel JM, Bestermann WH, Dyess EM, Graff A, Kursun A, Sutradhar S, Yunis C. The use of a single-pill calcium channel blocker/statin combination in the management of hypertension and dyslipidemia: a randomized, placebo-controlled, multicenter study. J Clin Hypertens (Greenwich). 2009 Jan;11(1):22-30. doi: 10.1111/j.1751-7176.2008.00058.x.
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