NCT03047538

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2017

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 7, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 9, 2017

Completed
7 months until next milestone

Study Start

First participant enrolled

September 1, 2017

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

June 21, 2019

Status Verified

June 1, 2019

Enrollment Period

2.3 years

First QC Date

February 7, 2017

Last Update Submit

June 19, 2019

Conditions

Arterial HypertensionDyslipidemiasBlood PressureLipid Metabolism Disorders

Keywords

Arterial hypertensionDyslipidemiaBlood pressure controlFixed combination

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (3)

  • Adherence

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

  • Blood pressure variability

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

  • Arterial properties

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

Study Arms (2)

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.

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.

Drug: Atorvastatin, Amlodipine, Perindopril

Interventions

Atorvastatin, Amlodipine, PerindoprilDRUG

To compare free and fixed combination of atorvastatin, perindopril, amlodipine

Fixed combinationFree combination

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • pregnancy
  • breastfeeding
  • Patients with contraindications listed in the currently valid SP

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Prague, 140 59, Czechia

Location

Related Publications (12)

  • 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.

    PMID: 18456100BACKGROUND

  • 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.

    PMID: 3946459BACKGROUND

  • 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.

    PMID: 20026768BACKGROUND

  • 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.

    PMID: 20479948BACKGROUND

  • 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.

    PMID: 20653798BACKGROUND

  • 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.

    PMID: 19125855BACKGROUND

  • 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.

    PMID: 21647425BACKGROUND

  • 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.

    PMID: 22815989BACKGROUND

  • 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.

    PMID: 19339045BACKGROUND

  • 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.

    PMID: 24002278BACKGROUND

  • 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.

    PMID: 21205325BACKGROUND

  • 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.

    PMID: 24707184BACKGROUND

MeSH Terms

Conditions

HypertensionDyslipidemiasLipid Metabolism Disorders

Interventions

AtorvastatinAmlodipinePerindopril

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipidsDihydropyridinesPyridinesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Peter Wohlfahrt, MD, PhD

Study Record Dates

First Submitted

February 7, 2017

First Posted

February 9, 2017

Study Start

September 1, 2017

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

June 21, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations

CZ(1)