Fixed Combination for Lipid and Blood Pressure Control

Blood Pressure Clinical Trial

— FILIP  

Official title:

Fixed Combination for Lipid and Blood Pressure Control. Randomized Cross-over Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03047538
• Other study ID #: FILIP_V1.2
• Status: Withdrawn
• Phase: Phase 4
• Start date: September 1, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: June 2019
• Source: Charles University, Czech Republic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arterial Hypertension
• Blood Pressure
• Dyslipidemias
• Hypertension
• Lipid Metabolism Disorders
• Metabolic Diseases

Intervention

Drug:
• Atorvastatin, Amlodipine, Perindopril
To compare free and fixed combination of atorvastatin, perindopril, amlodipine

Locations

Country	Name	City	State
Czechia	Center for Cardiovascular Prevention, Charles University Medical Faculty and Thomayer Hospital	Prague

Sponsors (7)

Lead Sponsor	Collaborator
Charles University, Czech Republic	Brno University Hospital, General Teaching Hospital, Prague, Na Homolce Hospital, St. Anne, University Hospital Olomouc, University Hospital Pilsen

Country where clinical trial is conducted

Czechia, 

References & Publications (12)

Cho EJ, Kim JH, Sutradhar S, Yunis C, Westergaard M; CRUCIAL trial investigators. Reduction in cardiovascular risk using a proactive multifactorial intervention is consistent among patients residing in Pacific Asian and non-Pacific Asian regions: a CRUCIAL trial subanalysis. Vasc Health Risk Manag. 2014 Mar 26;10:145-56. doi: 10.2147/VHRM.S54586. eCollection 2014. — View Citation

Grimm R, Malik M, Yunis C, Sutradhar S, Kursun A; TOGETHER Investigators. Simultaneous treatment to attain blood pressure and lipid goals and reduced CV risk burden using amlodipine/atorvastatin single-pill therapy in treated hypertensive participants in a randomized controlled trial. Vasc Health Risk Manag. 2010 May 6;6:261-71. — View Citation

Gupta AK, Arshad S, Poulter NR. Compliance, safety, and effectiveness of fixed-dose combinations of antihypertensive agents: a meta-analysis. Hypertension. 2010 Feb;55(2):399-407. doi: 10.1161/HYPERTENSIONAHA.109.139816. Epub 2009 Dec 21. Review. — View Citation

Indian Polycap Study (TIPS), Yusuf S, Pais P, Afzal R, Xavier D, Teo K, Eikelboom J, Sigamani A, Mohan V, Gupta R, Thomas N. Effects of a polypill (Polycap) on risk factors in middle-aged individuals without cardiovascular disease (TIPS): a phase II, double-blind, randomised trial. Lancet. 2009 Apr 18;373(9672):1341-51. doi: 10.1016/S0140-6736(09)60611-5. Epub 2009 Mar 30. — View 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. Review. — View Citation

Malekzadeh F, Marshall T, Pourshams A, Gharravi M, Aslani A, Nateghi A, Rastegarpanah M, Khoshnia M, Semnani S, Salahi R, Thomas GN, Larijani B, Cheng KK, Malekzadeh R. A pilot double-blind randomised placebo-controlled trial of the effects of fixed-dose combination therapy ('polypill') on cardiovascular risk factors. Int J Clin Pract. 2010 Aug;64(9):1220-7. doi: 10.1111/j.1742-1241.2010.02412.x. — View 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. — View Citation

PILL Collaborative Group, Rodgers A, Patel A, Berwanger O, Bots M, Grimm R, Grobbee DE, Jackson R, Neal B, Neaton J, Poulter N, Rafter N, Raju PK, Reddy S, Thom S, Vander Hoorn S, Webster R. An international randomised placebo-controlled trial of a four-component combination pill ("polypill") in people with raised cardiovascular risk. PLoS One. 2011;6(5):e19857. doi: 10.1371/journal.pone.0019857. Epub 2011 May 25. — View Citation

Soliman EZ, Mendis S, Dissanayake WP, Somasundaram NP, Gunaratne PS, Jayasingne IK, Furberg CD. A Polypill for primary prevention of cardiovascular disease: a feasibility study of the World Health Organization. Trials. 2011 Jan 5;12:3. doi: 10.1186/1745-6215-12-3. — View Citation

Stamler J, Wentworth D, Neaton JD. Prevalence and prognostic significance of hypercholesterolemia in men with hypertension. Prospective data on the primary screenees of the Multiple Risk Factor Intervention Trial. Am J Med. 1986 Feb 14;80(2A):33-9. — View Citation

Thom S, Poulter N, Field J, Patel A, Prabhakaran D, Stanton A, Grobbee DE, Bots ML, Reddy KS, Cidambi R, Bompoint S, Billot L, Rodgers A; UMPIRE Collaborative Group. Effects of a fixed-dose combination strategy on adherence and risk factors in patients with or at high risk of CVD: the UMPIRE randomized clinical trial. JAMA. 2013 Sep 4;310(9):918-29. doi: 10.1001/jama.2013.277064. Erratum in: JAMA. 2013 Oct 9;310(14):1507. Naik, Nitish [added]; Reddy, Srinivas [added]; Balaji, Sham [corrected to Achuthan, Shyambalaji]; Damodra Rao, Modem [corrected to Damodra Rao, Kodem]. — View Citation

Wald DS, Morris JK, Wald NJ. Randomized Polypill crossover trial in people aged 50 and over. PLoS One. 2012;7(7):e41297. doi: 10.1371/journal.pone.0041297. Epub 2012 Jul 18. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	16 weeks - 8 weeks fixed and 8 weeks free combination atorvastatin, perindopril, amlodipine
Primary	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.	16 weeks - 8 weeks fixed and 8 weeks free combination atorvastatin, perindopril, amlodipine
Secondary	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.	16 weeks - 8 weeks fixed and 8 weeks free combination atorvastatin, perindopril, amlodipine
Secondary	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.	16 weeks - 8 weeks fixed and 8 weeks free combination atorvastatin, perindopril, amlodipine
Secondary	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.	16 weeks - 8 weeks fixed and 8 weeks free combination atorvastatin, perindopril, amlodipine