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Telmisartan80/HCTZ25 Versus Telmisartan80/HCTZ12.5 in Hypertension Not Responding to Telmisartan80/HCTZ12.5

27. december 2017 opdateret af: Boehringer Ingelheim

A Prospective Randomised Study to Compare a Fixed Dose Combination of Telmisartan 80 mg Plus Hydrochlorothiazide 25 mg With a Fixed Dose Combination of Telmisartan 80 mg Plus Hydrochlorothiazide 12.5 mg in Patients With Uncontrolled Hypertension Who Fail to Respond Adequately to Treatment With a Fixed Dose Combination of Telmisartan 80 mg Plus Hydrochlorothiazide 12.5 mg

The primary objective of this trial is to demonstrate that a fixed dose combination of telmisartan 80 mg plus hydrochlorothiazide 25 mg (T80/H25) is superior in reducing blood pressure after eight weeks compared with a fixed dose combination of telmisartan 80 mg plus hydrochlorothiazide 12.5 mg (T80/H12.5) in patients who fail to respond to six weeks treatment with T80/H12.5.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Adult patients with high blood pressure who are currently taking one, two or three blood pressure treatments will be asked to take part in the study. It is expected that about 1,600 patients in seventeen countries will enter the screening part of the study and approximately 480 of these patients will be allocated to double-blind randomised study treatment. The study will last for approximately fifteen weeks. Patients will visit the study doctor five times for assessment. After informed consent, patients will start a screening period for four to ten days. During the screening period, patients must take their usual blood pressure treatment but will stop this by the date of the next visit. If the patient is suitable for this study, they will then start run-in treatment period with telmisartan 80 mg plus hydrochlorothiazide 12.5 mg (T80/H12.5) taken as a single tablet once per day for approximately six weeks.

At the end of the run-in treatment period, if the diastolic blood pressure (DBP) is below 90 mmHg, the patient will not proceed as their blood pressure is already controlled by T80/H12.5. If the DBP is 90 mmHg or greater they will start the randomised study treatment period and be randomly allocated to double-blind treatment with either telmisartan 80 mg plus hydrochlorothiazide 25 mg(T80/H25) or T80/H12.5 taken as a single tablet once per day for eight weeks. They will also receive a placebo tablet (a dummy tablet which contains no active ingredient) every day.

They will visit the clinic four weeks and eight weeks later for assessment of their blood pressure and general health. Their participation in the study is complete eight weeks after the start of the randomised treatment period.

Study Hypothesis:

The trial hypothesis is that the reduction in seated trough DBP (i.e., seated trough DBP at the end of the randomised treatment period compared with the seated trough DBP at the start of the randomised treatment period) will be greater in the T80/H25 group compared with the T80/H12.5 group.

Comparison(s):

The efficacy and safety of the two trial treatments (T80/H25 versus T80/H12.5) will be compared. Trough blood pressure is the blood pressure 24 hours after the last dose of trial medication.

Undersøgelsestype

Interventionel

Tilmelding

713

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Danmark
      • Birker?d, Danmark, 3460
        • Boehringer Ingelheim Investigational Site
      • Haderslev, Danmark, DK-6100
        • Boehringer Ingelheim Investigational Site
      • Odder, Danmark, DK-8300
        • Boehringer Ingelheim Investigational Site
      • R?dovre, Danmark, DK-2610
        • Boehringer Ingelheim Investigational Site
      • Vildbjerg, Danmark, DK-7480
        • Boehringer Ingelheim Investigational Site
  • Finland
      • Helsinki, Finland, FI-00500
        • Boehringer Ingelheim Investigational Site
      • Joensuu, Finland, FI-80100
        • Boehringer Ingelheim Investigational Site
      • Kokkola, Finland, FI-67200
        • Boehringer Ingelheim Investigational Site
      • Turku, Finland, FI-20100
        • Boehringer Ingelheim Investigational Site
      • Turku, Finland, FI-20520
        • Boehringer Ingelheim Investigational Site
  • Frankrig
      • Angers, Frankrig, 49000
        • ALTI
      • Angers, Frankrig, 49100
        • ALTI
      • Bobigny, Frankrig, 93000
        • Hôpital Avicenne
      • Paris, Frankrig, 75015
        • Mg Recherches
  • Holland
      • Bennebroek, Holland, 2121 BB
        • Boehringer Ingelheim Investigational Site
      • Ewijk, Holland, 6644 CL
        • Boehringer Ingelheim Investigational Site
      • Helmond, Holland, 5704 CM
        • Boehringer Ingelheim Investigational Site
      • Hoogwoud, Holland, 1817 BG
        • Boehringer Ingelheim Investigational Site
      • Nijverdal, Holland, 7442 LS
        • Boehringer Ingelheim Investigational Site
      • Oude Pekela, Holland, 9665 BJ
        • Boehringer Ingelheim Investigational Site
      • Oude Pekela, Holland, 9665 AR
        • Boehringer Ingelheim Investigational Site
      • Rijswijk, Holland, 2281 AK
        • Boehringer Ingelheim Investigational Site
      • Roelofarendsveen, Holland, 2371 RB
        • Boehringer Ingelheim Investigational Site
      • Rotterdam, Holland, 3082 DC
        • Boehringer Ingelheim Investigational Site
  • Hong Kong
      • Hong Kong, Hong Kong
        • Boehringer Ingelheim Investigational Site
  • Irland
      • Birr, Irland
        • Boehringer Ingelheim Investigational Site
      • Carrigallen, Irland
        • Boehringer Ingelheim Investigational Site
      • Dublin 18, Irland
        • Boehringer Ingelheim Investigational Site
      • Dublin 24, Irland
        • Boehringer Ingelheim Investigational Site
      • Dublin 9, Irland
        • Boehringer Ingelheim Investigational Site
      • Enniscorthy,, Irland
        • Boehringer Ingelheim Investigational Site
      • Gorey, Irland
        • Boehringer Ingelheim Investigational Site
      • Mallow, Irland
        • Boehringer Ingelheim Investigational Site
      • New Ross, Irland
        • Boehringer Ingelheim Investigational Site
      • Toomevara, Irland
        • Boehringer Ingelheim Investigational Site
  • Italien
      • Broni (PV), Italien, 27043
        • Ospedale Arnaboldi
      • Ferrara, Italien, 44100
        • Azienda Ospedaliera Universita di Ferrara
      • Roma, Italien, 00163
        • IRCCS San Raffaele
      • Vittorio Veneto (TV), Italien, 31029
        • Ospedale Civile
  • Korea, Republikken
      • Incheon, Korea, Republikken, 405760
        • Boehringer Ingelheim Investigational Site
      • Seoul, Korea, Republikken, 134701
        • Boehringer Ingelheim Investigational Site
      • Seoul, Korea, Republikken, 152703
        • Boehringer Ingelheim Investigational Site
  • Malaysia
      • Kuching, Sarawak, Malaysia, 93586
        • Boehringer Ingelheim Investigational Site
  • Norge
      • Elverum, Norge, N-2408
        • Boehringer Ingelheim Investigational Site
      • Moelv, Norge, N-2391
        • Boehringer Ingelheim Investigational Site
      • Oslo, Norge, N-0369
        • Boehringer Ingelheim Investigational Site
      • Skedsmokorset, Norge, N-2020
        • Boehringer Ingelheim Investigational Site
      • Tolvsr?d, Norge, N-3153
        • Boehringer Ingelheim Investigational Site
  • Schweiz
      • Basel, Schweiz, 4031
        • Boehringer Ingelheim Investigational Site
      • Basel, Schweiz, 4051
        • Boehringer Ingelheim Investigational Site
      • Basel, Schweiz, 4052
        • Boehringer Ingelheim Investigational Site
      • Bellinzona, Schweiz, 6500
        • Boehringer Ingelheim Investigational Site
      • St. Imier, Schweiz, 2610
        • Boehringer Ingelheim Investigational Site
      • Vezia, Schweiz, 6943
        • Boehringer Ingelheim Investigational Site
  • Spanien
      • Badalona / Barcelona, Spanien, 08911
        • Hospital Municipal de Badalona
      • Galdakao / Vizcaya, Spanien, 48680
        • Hospital de Galdakao
      • Jerez De La Frontera / Cadiz, Spanien, 11407
        • Hospital Gral. Jerez de la Frontera
      • L'Hospitalet De Llobregat / Barcelona, Spanien, 08902
        • C.A.P. Mosen Cinto Verdaguer
      • Madrid, Spanien, 28007
        • Hospital Universitario Gregorio Mara?on
      • Mataro (Barcelona), Spanien, 08303
        • C.A.P. Ronda Cerdanya
      • Mostoles / Madrid, Spanien, 28935
        • Hospital General de Mostoles - Medicina Interna
      • Santiago de Compostela, Spanien, 15706
        • Hospital del Conxo
  • Sverige
      • Eksjo, Sverige, 575 36
        • Boehringer Ingelheim Investigational Site
      • Karlstad, Sverige, 651 85
        • Boehringer Ingelheim Investigational Site
      • Karlstad, Sverige, 652 24
        • Boehringer Ingelheim Investigational Site
      • Uddevalla, Sverige, 451 40
        • Boehringer Ingelheim Investigational Site
      • Uppsala, Sverige, 751 25
        • Boehringer Ingelheim Investigational Site
  • Sydafrika
      • Bellville, Sydafrika, 7531
        • Boehringer Ingelheim Investigational Site
      • Durban, Sydafrika, 4091
        • Boehringer Ingelheim Investigational Site
      • Johannesburg, Sydafrika, 2001
        • Boehringer Ingelheim Investigational Site
      • Johannesburg, Sydafrika, 2013
        • Boehringer Ingelheim Investigational Site
      • Lenasia, Sydafrika, 2033
        • Boehringer Ingelheim Investigational Site
      • Lenasia South, Sydafrika, 2033
        • Boehringer Ingelheim Investigational Site
      • Midrand, Sydafrika, 1685
        • Boehringer Ingelheim Investigational Site
      • Pretoria, Sydafrika, 0038
        • Boehringer Ingelheim Investigational Site
  • Taiwan
      • Taipei, Taiwan
        • Boehringer Ingelheim Investigational Site
      • Taipei, Taiwan, 112
        • Boehringer Ingelheim Investigational Site
      • Taipei, Taiwan, 104
        • Boehringer Ingelheim Investigational Site
  • Tyskland
      • Ellefeld, Tyskland, 08236
        • Boehringer Ingelheim Investigational Site
      • Florsheim, Tyskland, 65439
        • Boehringer Ingelheim Investigational Site
      • Frankfurt/Main, Tyskland, 60323
        • Boehringer Ingelheim Investigational Site
      • Haag, Tyskland, 83527
        • Boehringer Ingelheim Investigational Site
      • Ingelheim, Tyskland, 55218
        • Boehringer Ingelheim Investigational Site
      • Nurnberg, Tyskland, 90402
        • Boehringer Ingelheim Investigational Site
      • Rodgau-Dudenhofen, Tyskland, 63110
        • Boehringer Ingelheim Investigational Site
      • Unterschneidheim, Tyskland, 73485
        • Boehringer Ingelheim Investigational Site

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 og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion criteria:

  • Essential hypertension.
  • Currently taking between one and three antihypertensive medications at a stable dose for at least four weeks before Visit 1.
  • Blood pressure not adequately controlled on existing treatment before entry (inadequate control defined as seated DBP >= 95 mmHg on one current antihypertensive medication or DBP >= 90 mmHg on two or more current antihypertensive medication(s).
  • Failure to respond to six weeks treatment with T80/H12.5. (Failure to respond defined as seated DBP >= 90 mmHg at six weeks. This criterion will be assessed at Visit 3.)
  • Willing and able to provide written informed consent.

Exclusion criteria:

  • Women of child-bearing potential NOT practising acceptable means of birth control, positive serum pregnancy test, breastfeeding.
  • Known or suspected secondary hypertension.
  • Mean SBP >= 200 mmHg.
  • Severe hepatic or renal impairment.
  • Bilateral renal artery stenosis (or in a solitary kidney), post-renal transplant or only one functioning kidney.
  • Clinically relevant hypokalaemia or hyperkalaemia.
  • Uncorrected volume or sodium depletion, primary aldosteronism.
  • Hereditary fructose intolerance.
  • Previous symptoms of angioedema after ACE inhibitors or angiotensin-II receptor antagonists.
  • Drug or alcohol dependency within the previous six months.
  • Administration of any medication known to affect blood pressure.
  • Concurrent participation in another clinical trial or any investigational therapy.
  • Hypertrophic obstructive cardiomyopathy, hemodynamically relevant stenosis of the aortic or mitral valve.
  • Allergic hypersensitivity to any component of the formulations under investigation.
  • Concomitant therapy with lithium, cholestyramine or colestipol resins. non-compliance with study medication (less than 80% or more than 120%) during th e run-in treatment period.
  • Any other clinical condition which, in the opinion of the investigator, would not allow safe administration of telmisartan or hydrochlorothiazide.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Change from baseline in trough seated DBP
Tidsramme: 8 weeks
8 weeks

Sekundære resultatmål

Resultatmål
Tidsramme
Change from baseline in trough seated SBP
Tidsramme: 8 weeks
8 weeks
Change from baseline in trough standing DBP and SBP
Tidsramme: 8 weeks
8 weeks
The proportion of patients achieving DBP control (trough seated DBP<90 mmHg).
Tidsramme: 8 weeks
8 weeks
The proportion of patients achieving DBP response (trough seated DBP<90 mmHg or trough seated DBP reduction from baseline ≥10 mmHg).
Tidsramme: 8 weeks
8 weeks
The proportion of patients achieving SBP response (trough seated SBP<140 mmHg or trough seated SBP reduction from baseline ≥10 mmHg).
Tidsramme: 8 weeks
8 weeks
The proportion of patients achieving SBP response (trough seated SBP<140 mmHg or trough seated SBP reduction from baseline ≥20 mmHg)
Tidsramme: 8 weeks
8 weeks
The proportion of patients in trough seated BP categories: opt.: SBP<120 mmHg and DBP<80 mmHg., norm.: SBP<130 mmHg and DBP<85 mmHg and not optimal, high-normal: SBP<140 mmHg and DBP<90 mmHg and not optimal or normal, high: SBP ≥140 mmHg or DBP ≥90 mmHg
Tidsramme: 8 weeks
8 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Boehringer Ingelheim

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.

Hjælpsomme links

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. oktober 2005

Primær færdiggørelse (Faktiske)

1. august 2006

Studieafslutning

1. august 2006

Datoer for studieregistrering

Først indsendt

13. oktober 2005

Først indsendt, der opfyldte QC-kriterier

13. oktober 2005

Først opslået (Skøn)

17. oktober 2005

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

28. december 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. december 2017

Sidst verificeret

1. december 2017

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 502.480

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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