- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01047423
Targeting Microvascular Dysfunction in Young Hypertensive Patients
1. juli 2019 opdateret af: Gary E McVeigh, Queen's University, Belfast
Cholesterol and blood pressure lowering tablets have been shown to be of benefit in patients with established high blood pressure.
High blood pressure is a very common medical condition that can lead to vascular complications i.e. problems with the blood vessels in the body.
One way of detecting early changes in these blood vessels as a result of high blood pressure is to measure their compliance/flexibility with a noninvasive technique known as ultrasound and with a simple blood test.
The investigators are trying to establish whether these early changes in blood vessels can be significantly improved by the use of both a cholesterol and blood pressure lowering tablet at an earlier stage than is currently advised.
The investigators hope that the early combination of these tablets will prove more effective than the use of a blood pressure lowering tablet by itself and therefore possibly reduce the risk of long term complications developing.
Studieoversigt
Status
Trukket tilbage
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Fase
- Fase 4
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
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Belfast, Det Forenede Kongerige, BT9 7BL
- Belfast Health and Social Care Trust
-
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 60 år (Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
To be eligible for the study, all of the following criteria must be met:
- All patients must have a diagnosis of essential hypertension with off treatment systolic pressure >140 mmHg and/or diastolic pressure >90 mmHg, measured at rest in the seated position on at least two separate occasions, at least 2 weeks apart.
- Patients will be < 50 years for men and < 60 years for women.
- Female patients of childbearing potential must be using a medically accepted means of contraception (that is, interuterine device, oral contraceptive, implant, DepoProvera or barrier devices). Female patients of childbearing age will be screened with a pregnancy test.
- Patients will be typically already on antihypertensive therapy.
- Patients must have a level of understanding sufficient to complete all tests and examinations required by the protocol and are able to understand and give informed consent.
Exclusion Criteria:
Patients will be excluded from the study if they meet any of the following criteria:
- A history of diabetes mellitus, coronary artery or cerebrovascular disease, hypertensive retinopathy, hypertensive nephropathy, left ventricular hypertrophy or hyperlipidaemia warranting treatment as defined by the latest NICE guidelines which recommend an age based treatment strategy rather than one driven purely by lipid levels in isolation.
- Abnormal baseline liver function (defined as AST or ALT > 3 times upper limit of normal), raised baseline creatinine kinase (CK) (defined as CK > 200 mmol/L), severe renal impairment (defined as estimated glomerular filtration rate (eGFR) < 30 mls/minute) or previous adverse event relating to either an ARB or statin in the past.
- Female patients will be excluded if they are pregnant, intend to be pregnant or are lactating. Female patients of childbearing age will be screened with a pregnancy test.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Simvastatin
40mg Simvastatin once daily for 12 weeks followed by 4 week washout period followed by placebo for 12 weeks
|
40mg encapsulated once daily for 12 weeks
|
|
Placebo komparator: Placebo
Placebo for 12 weeks followed by 4 week washout period followed by 40mg Simvastatin once daily for 12 weeks
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Encapsulated oral once daily for 12 weeks
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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To demonstrate a significant difference in flow-mediated dilatation of the brachial artery and microvasculature between groups.
Tidsramme: 0, 3, 4 and 7 months
|
0, 3, 4 and 7 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Gary E McVeigh, FRCP PhD, Queen's University, Belfast
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. august 2009
Primær færdiggørelse (Forventet)
1. august 2011
Studieafslutning (Forventet)
1. august 2011
Datoer for studieregistrering
Først indsendt
11. januar 2010
Først indsendt, der opfyldte QC-kriterier
11. januar 2010
Først opslået (Skøn)
12. januar 2010
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
5. juli 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
1. juli 2019
Sidst verificeret
1. juli 2019
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2009-011638-90
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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