Additional Effect of A Life Style Program on Antihypertensive Treatment With Telmisartan
perjantai 28. helmikuuta 2014 päivittänyt: Boehringer Ingelheim
Additional Effect of a Life Style Program on Antihypertensive Treatment With Telmisartan
This post-marketing surveillance study is designed to supplement the data on efficacy and tolerability of Micardis® and MicardisPlus® in patients at cardiovascular risk under general practice conditions.
The aim of the study is to investigate the effect of a six-month treatment with Micardis® / MicardisPlus® on blood pressure and the effect of the Lifestyle education tool for weight reduction on blood pressure control.
In addition, the post-marketing surveillance study will provide information on the effects on target measurement of the Lifestyle education tool and various laboratory parameters produced by treatment with Micardis® and MicardisPlus® in an unselected patient population under general practice conditions.
Tutkimuksen yleiskatsaus
Tila
Valmis
Ehdot
Opintotyyppi
Havainnollistava
Ilmoittautuminen (Todellinen)
1856
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskelupaikat
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Banská Bystrica, Slovenia
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Banská Bystrica, Slovenia
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Banská Bystrica, Slovenia
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Banská Bystrica, Slovenia
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Banská Bystrica, Slovenia
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Banská Bystrica, Slovenia
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Bardejov, Slovenia
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Bardejov, Slovenia
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Bratislava, Slovenia
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Bratislava, Slovenia
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Bratislava, Slovenia
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Brezno, Slovenia
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Dunajská Streda, Slovenia
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Dunajská Streda, Slovenia
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Dunajská Streda, Slovenia
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Dunajská Streda, Slovenia
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Dunajská Streda, Slovenia
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Dunajská Streda, Slovenia
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Handlová, Slovenia
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Kosice, Slovenia
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Kosice, Slovenia
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Kosice, Slovenia
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Kosice, Slovenia
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Kosice, Slovenia
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Kosice, Slovenia
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Kosice, Slovenia
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Kosice, Slovenia
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Kosice, Slovenia
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Kosice, Slovenia
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Kosice, Slovenia
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Kosice, Slovenia
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Kosice, Slovenia
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Kosice, Slovenia
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Krá?ovský Chlmec, Slovenia
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Kysucké Nové Mesto, Slovenia
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Kysucké Nové Mesto, Slovenia
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Kysucké Nové Mesto, Slovenia
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Levice, Slovenia
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Levice, Slovenia
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Levice, Slovenia
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Lipany, Slovenia
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Lu?enec, Slovenia
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Lu?enec, Slovenia
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Lu?enec, Slovenia
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Lu?enec, Slovenia
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Martin, Slovenia
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Martin, Slovenia
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Martin, Slovenia
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Michalovce, Slovenia
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Michalovce, Slovenia
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Michalovce, Slovenia
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Myjava, Slovenia
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Nitra, Slovenia
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Nitra, Slovenia
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Nitra, Slovenia
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Nitra, Slovenia
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Nové Mesto nad Váhom, Slovenia
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Nové Mesto nad Váhom, Slovenia
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Nové Mesto nad Váhom, Slovenia
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Nové Zámky, Slovenia
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Nové Zámky, Slovenia
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Nové Zámky, Slovenia
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Nové Zámky, Slovenia
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Námestovo, Slovenia
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Partizánske, Slovenia
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Partizánske, Slovenia
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Pezinok, Slovenia
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Pies?any, Slovenia
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Poprad, Slovenia
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Poprad, Slovenia
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Poprad, Slovenia
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Povazská Bystrica, Slovenia
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Povazská Bystrica, Slovenia
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Presov, Slovenia
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Presov, Slovenia
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Presov, Slovenia
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Presov, Slovenia
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Prievidza, Slovenia
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Prievidza, Slovenia
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Prievidza, Slovenia
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Rajec, Slovenia
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Revúca, Slovenia
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Revúca, Slovenia
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Rimavská Sobota, Slovenia
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Rimavská Sobota, Slovenia
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Rimavská Sobota, Slovenia
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Roz?ava, Slovenia
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Roz?ava, Slovenia
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Ruzomberok, Slovenia
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Ruzomberok, Slovenia
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Sa?a, Slovenia
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Sa?a, Slovenia
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Sa?a, Slovenia
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Se?ovce, Slovenia
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Se?ovce, Slovenia
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Skalica, Slovenia
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Snina, Slovenia
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Snina, Slovenia
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Spisská Nová Ves, Slovenia
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Spisská Nová Ves, Slovenia
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Stará ?ubov?a, Slovenia
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Stará ?ubov?a, Slovenia
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Stará ?ubov?a, Slovenia
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Stropkov, Slovenia
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Stúrovo, Slovenia
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Surany, Slovenia
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Surany, Slovenia
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Svit, Slovenia
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Topo??any, Slovenia
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Torna?a, Slovenia
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Trebisov, Slovenia
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Trebisov, Slovenia
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Trebisov, Slovenia
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Tren?ín, Slovenia
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Tren?ín, Slovenia
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Tren?ín, Slovenia
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Tren?ín, Slovenia
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Trnava, Slovenia
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Trnava, Slovenia
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Trnava, Slovenia
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Trnava, Slovenia
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Trstená, Slovenia
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Tur?ianske Teplice, Slovenia
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Ve?ké Kapusany, Slovenia
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Vranov nad Top?ou, Slovenia
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Vráble, Slovenia
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Zarnovica, Slovenia
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Zeliezovce, Slovenia
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Zilina, Slovenia
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Zilina, Slovenia
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Zilina, Slovenia
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Zilina, Slovenia
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Zlaté Moravce, Slovenia
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Zlaté Moravce, Slovenia
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Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
18 vuotta ja vanhemmat (Aikuinen, Vanhempi Aikuinen)
Hyväksyy terveitä vapaaehtoisia
Ei
Sukupuolet, jotka voivat opiskella
Kaikki
Näytteenottomenetelmä
Todennäköisyysnäyte
Tutkimusväestö
Patients with hypertension
Kuvaus
Inclusion criteria:
- Patients with essential hypertension (blood pressure (BP) higher or equal to 140/90 mmHg or higher or equal to 130/80 mmHg in case of diabetic patients)
- Patients with hypertension under treatment with one or more antihypertensive drug
Exclusion criteria:
Patients are excluded according to the summary of product characteristics (SmPC).
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
Kohortit ja interventiot
Ryhmä/Kohortti |
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Patients at cardiovascular risk
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Changes in Mean Blood Pressure (Systolic) After Treatment, Compared to Baseline
Aikaikkuna: 24 weeks (Visit 1 to Visit 3)
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Changes in blood pressure in patients with systolic values, measured at baseline and final visit, by treatment and by Tool/No Tool
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24 weeks (Visit 1 to Visit 3)
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Changes in Mean Blood Pressure (Diastolic) After Treatment, Compared to Baseline
Aikaikkuna: 24 weeks (Visit 1 to Visit 3)
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Changes in blood pressure in patients with diastolic values, measured at baseline and final visit, by treatment and by Tool/No Tool
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24 weeks (Visit 1 to Visit 3)
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Changes in Laboratory Parameters:Low Density Lipoprotein (LDL)
Aikaikkuna: 24 weeks (Visit 1 to Visit 3)
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Changes in LDL cholesterol levels from baseline to final visit in patients with both laboratory values valid, by treatment and by Tool/No Tool
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24 weeks (Visit 1 to Visit 3)
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Changes in Laboratory Parameters:High Density Lipoprotein (HDL)
Aikaikkuna: 24 weeks (Visit 1 to Visit 3)
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Changes in LDL cholesterol levels from baseline to final visit in patients with both laboratory values valid, by treatment and by Tool/No Tool
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24 weeks (Visit 1 to Visit 3)
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Changes in Laboratory Parameters: Triglycerides
Aikaikkuna: 24 weeks (Visit 1 to Visit 3)
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Changes in the triglyceride levels from baseline to final visit in patients with both laboratory values valid, by treatment and by Tool/No Tool
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24 weeks (Visit 1 to Visit 3)
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Changes in Laboratory Parameters: Blood Glucose
Aikaikkuna: 24 weeks (Visit 1 to Visit 3)
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Changes in the fasting blood glucose levels from baseline to final visit in patients with both laboratory values valid, by treatment and by Tool/No Tool
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24 weeks (Visit 1 to Visit 3)
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Assessment of Metabolic Effect
Aikaikkuna: 24 weeks (Visit 1 to Visit 3)
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Metabolic effect was rated by the investigators as 'positive', 'neutral' and 'negative'
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24 weeks (Visit 1 to Visit 3)
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Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Julkaisuja ja hyödyllisiä linkkejä
Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.
Hyödyllisiä linkkejä
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Maanantai 1. syyskuuta 2008
Ensisijainen valmistuminen (Todellinen)
Tiistai 1. syyskuuta 2009
Opintojen valmistuminen (Todellinen)
Tiistai 1. syyskuuta 2009
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Torstai 11. maaliskuuta 2010
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Keskiviikko 21. huhtikuuta 2010
Ensimmäinen Lähetetty (Arvio)
Torstai 22. huhtikuuta 2010
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Arvio)
Torstai 10. huhtikuuta 2014
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Perjantai 28. helmikuuta 2014
Viimeksi vahvistettu
Lauantai 1. helmikuuta 2014
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- 502.579
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .