Arterial HypertensionPhase 4FILIPNCT03047538

Fixed Combination for Lipid and Blood Pressure Control

A Phase 4 study testing Atorvastatin, Amlodipine, Perindopril in people with Arterial Hypertension and Dyslipidemias, run by Charles University, Czech Republic at 1 site in Czechia.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

Search all trials

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Arterial Hypertension, Dyslipidemias, Blood Pressure
What is being tested?: Atorvastatin, Amlodipine, Perindopril
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: 1 siteCzechia
Study dates: 1 Sep 2017to 31 Dec 2019
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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:
a very high cardiovascular risk and LDL-cholesterol> 1.8 mmol / l
a high cardiovascular risk and LDL-cholesterol> 2.5 mmol / l
Patient with a high or very high cardiovascular risk treated by lipidlowering therapy with statin

Who cannot join

hypersensitivity to perindopril or to other ACE inhibitors, amlodipine, atorvastatin, dihydropyridines or to or statins
angioneurotic edema in medical history (hereditary / idiopathic or associated with prior treatment with ACE inhibitors)
severe hypotension, shock, including cardiogenic shock
hemodynamically unstable heart failure
Active liver disease or unexplained persistent elevations of serum transaminases more than three times normal
Women of childbearing age without reliable contraception

Show all 9Show fewer

pregnancy
breastfeeding
Patients with contraindications listed in the currently valid SP

Trial locations and contacts

1 site in 1 country.

Czechia1 site

Center for Cardiovascular Prevention, Charles University Medical Faculty and Thomayer Hospital
Prague, 140 59

Other trials in Czechia

About this study

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

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.

Conditions: Arterial Hypertension, Dyslipidemias, Blood Pressure, Lipid Metabolism Disorders
Being tested: Atorvastatin, Amlodipine, Perindopril
Keywords: Arterial hypertension, Dyslipidemia, Blood pressure control, Fixed combination
Medical subject headings: Hypertension, Dyslipidemias, Lipid Metabolism Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Atorvastatin, Amlodipine, PerindoprilDrug
To compare free and fixed combination of atorvastatin, perindopril, amlodipine

Study groups in NCT03047538
Study group	Role	What they receive
Free combination	Active comparator	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. Receives: Drug: Atorvastatin, Amlodipine, Perindopril
Fixed combination	Active comparator	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. Receives: Drug: Atorvastatin, Amlodipine, Perindopril

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 16 weeks - 8 weeks fixed and 8 weeks free combination atorvastatin, perindopril, amlodipine
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.
Measured: 16 weeks - 8 weeks fixed and 8 weeks free combination atorvastatin, perindopril, amlodipine

Secondary outcomes (3)

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.
Measured: 16 weeks - 8 weeks fixed and 8 weeks free combination atorvastatin, perindopril, amlodipine
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.
Measured: 16 weeks - 8 weeks fixed and 8 weeks free combination atorvastatin, perindopril, amlodipine
Arterial properties
- 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.
Measured: 16 weeks - 8 weeks fixed and 8 weeks free combination atorvastatin, perindopril, amlodipine

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 201731 Dec 2019

First posted9 Feb 2017 (estimated)
Study start1 Sep 2017
Primary completion31 Dec 2019 (estimated)
Study completion31 Dec 2019 (estimated)

Why it stopped: Insufficient funds

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (12)Papers the sponsor has linked to this study.
Other trials for Arterial HypertensionStudies of the same condition, open and under way.
More trials run by Charles University, Czech RepublicThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03047538
Sponsor's protocol ID: FILIP_V1.2
Acronym: FILIP
Status last verified: Jun 2019
First submitted: 7 Feb 2017
Last updated: 21 Jun 2019
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 18456100
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. doi: 10.1016/0002-9343(86)90158-0.
PubMed 3946459
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.
PubMed 20026768
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. doi: 10.2147/vhrm.s7710.
PubMed 20479948
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.
PubMed 20653798
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.
PubMed 19125855
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.
PubMed 21647425
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.
PubMed 22815989
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.
PubMed 19339045
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.
PubMed 24002278
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.
PubMed 21205325
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.
PubMed 24707184

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 21 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Fixed Combination for Lipid and Blood Pressure Control. Randomized Cross-over Study
ClinicalTrials.gov ID: NCT03047538
Acronym / sponsor ID: FILIP / FILIP_V1.2
Conditions: Arterial Hypertension, Dyslipidemias, Blood Pressure, Lipid Metabolism Disorders
Keywords: Arterial hypertension, Dyslipidemia, Blood pressure control, Fixed combination
Phase: Phase 4
Study type: Interventional
Recruitment status: WithdrawnReason stopped: Insufficient funds
Enrolment: 0 participants (actual)
Lead sponsor: Charles University, Czech RepublicUniversity, hospital or other
Collaborators: University Hospital Olomouc, University Hospital Pilsen, General Teaching Hospital, Prague, St. Anne, Brno University Hospital, Na Homolce Hospital
Study start: 1 Sep 2017 (actual)
Primary completion: 31 Dec 2019 (estimated)
Study completion: 31 Dec 2019 (estimated)
First posted: 9 Feb 2017 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Free combination	Active comparator	Drug: Atorvastatin, Amlodipine, PerindoprilFree 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	Active comparator	Drug: Atorvastatin, Amlodipine, PerindoprilFixed 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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:
a very high cardiovascular risk and LDL-cholesterol> 1.8 mmol / l
a high cardiovascular risk and LDL-cholesterol> 2.5 mmol / l
Patient with a high or very high cardiovascular risk treated by lipidlowering therapy with statin

Key exclusion criteria (9 listed)

hypersensitivity to perindopril or to other ACE inhibitors, amlodipine, atorvastatin, dihydropyridines or to or statins
angioneurotic edema in medical history (hereditary / idiopathic or associated with prior treatment with ACE inhibitors)
severe hypotension, shock, including cardiogenic shock
hemodynamically unstable heart failure
Active liver disease or unexplained persistent elevations of serum transaminases more than three times normal

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Atorvastatin, Amlodipine, PerindoprilTo compare free and fixed combination of atorvastatin, perindopril, amlodipine	Drug	Fixed combination, Free combination

Primary outcome

Blood pressure control
Time frame: 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
Time frame: 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.

3 secondary outcomes

Adherence
Time frame: 16 weeks - 8 weeks fixed and 8 weeks free combination atorvastatin, perindopril, amlodipine
Blood pressure variability
Time frame: 16 weeks - 8 weeks fixed and 8 weeks free combination atorvastatin, perindopril, amlodipine
Arterial properties
Time frame: 16 weeks - 8 weeks fixed and 8 weeks free combination atorvastatin, perindopril, amlodipine

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2019.
Background: PubMed 18456100Lawes 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.
Background: PubMed 3946459Stamler 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. doi: 10.1016/0002-9343(86)90158-0.
Background: PubMed 20026768Gupta 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.
Background: PubMed 20479948Grimm 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. doi: 10.2147/vhrm.s7710.
Background: PubMed 20653798Malekzadeh 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.
Background: PubMed 19125855Neutel 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.
Background: PubMed 21647425PILL 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.
Background: PubMed 22815989Wald 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.
Background: PubMed 19339045Indian 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.
Background: PubMed 24002278Thom 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.
Background: PubMed 21205325Soliman 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.
Background: PubMed 24707184Cho 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Atorvastatin, Amlodipine, Perindopril in people with Arterial Hypertension and Dyslipidemias, run by Charles University, Czech Republic at 1 site in Czechia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 21 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Blood pressure control (time frame: 16 weeks - 8 weeks fixed and 8 weeks free combination atorvastatin, perindopril, amlodipine). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03047538, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2019.