Telmisartan/Amlodipine (80/5) vs. Telmisartan/Amlodipine (40/5) vs. Amlodipine 10 or 5 in Resistant Hypertension

Last updated: June 17, 2014
Sponsor: Boehringer Ingelheim
Overall Status: Completed

Phase

3

Condition

Stress

Williams Syndrome

Circulation Disorders

Treatment

N/A

Clinical Study ID

NCT00558428
1235.5
EUDRACT2007-002409-36
  • Ages > 18
  • All Genders

Study Summary

The primary objectives of this trial are (a) to demonstrate that the fixed-dose combination T40/A5 or the fixed-dose combination T80/A5 is superior in reducing blood pressure at eight weeks compared with A5 (b) to demonstrate that the fixed-dose combination T40/A5 or the fixed-dose combination T80/A5 is not inferior in reducing blood pressure at eight weeks compared with A10 and (c) to demonstrate that the incidence of oedema on the fixed-dose combination T40/A5 pooled with the fixed-dose combination T80/A5 is superior (less oedema) to A10 in patients who fail to respond adequately to six weeks treatment with A5.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. patients aged at least 18 years at the date of signing the consent form

  2. diagnosis of essential hypertension and blood pressure not adequately controlledbefore enrolment in the study

  3. failure to respond adequately to six weeks treatment with amlodipine 5 mg monotherapy

  4. able to stop any current antihypertensive therapy without unacceptable risk to thepatient (Investigator's decision)

  5. willing and able to provide written informed consent (in accordance with Good ClinicalPractice and local legislation).

Exclusion

Exclusion Criteria:

  1. are not practising acceptable means of birth control or do not plan to continue usingacceptable means of birth control throughout the study and do not agree to submit topregnancy testing during participation in the trial. Acceptable methods of birthcontrol include the transdermal patch, oral, implantable or injectable contraceptives,sexual abstinence and vasectomised partner.

  2. known or suspected secondary hypertension

  3. mean seated systolic blood pressure (SBP) over 200 mmHg and/or mean seated diastolicblood pressure (DBP) over 120 mmHg at Visit 1 or 2 or mean seated SBP over 180 mmHgand/or mean seated DBP over 120 mmHg at the end of the run-in period (Visit 3)

  4. any clinically significant hepatic impairment (e.g. clinically significantcholestasis, biliary obstructive disorder or hepatic insufficiency)

  5. severe renal impairment (e.g. serum creatinine >3.0 mg/dL or >265 mcmol/L, knowncreatinine clearance <30mL/min or clinical markers of severe renal impairment)

  6. bilateral renal artery stenosis or renal artery stenosis in a solitary kidney orpost-renal transplant

  7. clinically relevant hyperkalaemia

  8. uncorrected volume or sodium depletion.

  9. primary aldosteronism.

  10. hereditary fructose or lactose intolerance

Study Design

Total Participants: 1098
Study Start date:
October 01, 2007
Estimated Completion Date:

Connect with a study center

  • 1235.5.32004 Boehringer Ingelheim Investigational Site

    Aywaille,
    Belgium

    Site Not Available

  • 1235.5.32001 Boehringer Ingelheim Investigational Site

    Bruxelles,
    Belgium

    Site Not Available

  • 1235.5.32010 Boehringer Ingelheim Investigational Site

    Gozée,
    Belgium

    Site Not Available

  • 1235.5.32010 Boehringer Ingelheim Investigational Site

    Gozée,
    Belgium

    Site Not Available

  • 1235.5.32008 Boehringer Ingelheim Investigational Site

    Linkebeek,
    Belgium

    Site Not Available

  • 1235.5.32003 Boehringer Ingelheim Investigational Site

    Mol,
    Belgium

    Site Not Available

  • 1235.5.32007 Boehringer Ingelheim Investigational Site

    Natoye,
    Belgium

    Site Not Available

  • 1235.5.32009 Boehringer Ingelheim Investigational Site

    Tavier,
    Belgium

    Site Not Available

  • 1235.5.32002 Boehringer Ingelheim Investigational Site

    Tienen-Kumtich,
    Belgium

    Site Not Available

  • 1235.5.32005 Boehringer Ingelheim Investigational Site

    Turnhout,
    Belgium

    Site Not Available

  • 1235.5.20001 Boehringer Ingelheim Investigational Site

    Coquitlam, British Columbia
    Canada

    Site Not Available

  • 1235.5.20011 Boehringer Ingelheim Investigational Site

    Vancouver, British Columbia
    Canada

    Site Not Available

  • 1235.5.20007 Boehringer Ingelheim Investigational Site

    Bay Roberts, Newfoundland and Labrador
    Canada

    Site Not Available

  • 1235.5.20005 Boehringer Ingelheim Investigational Site

    Mount Pearl, Newfoundland and Labrador
    Canada

    Site Not Available

  • 1235.5.20008 Boehringer Ingelheim Investigational Site

    St. John's, Newfoundland and Labrador
    Canada

    Site Not Available

  • 1235.5.20013 Boehringer Ingelheim Investigational Site

    Corunna, Ontario
    Canada

    Site Not Available

  • 1235.5.20014 Boehringer Ingelheim Investigational Site

    Etobicoke, Ontario
    Canada

    Site Not Available

  • 1235.5.20010 Boehringer Ingelheim Investigational Site

    Hamilton, Ontario
    Canada

    Site Not Available

  • 1235.5.20012 Boehringer Ingelheim Investigational Site

    London, Ontario
    Canada

    Site Not Available

  • 1235.5.20009 Boehringer Ingelheim Investigational Site

    Ottawa, Ontario
    Canada

    Site Not Available

  • 1235.5.20006 Boehringer Ingelheim Investigational Site

    Sarnia, Ontario
    Canada

    Site Not Available

  • 1235.5.20003 Boehringer Ingelheim Investigational Site

    Sainte-Foy, Quebec
    Canada

    Site Not Available

  • 1235.5.45002 Boehringer Ingelheim Investigational Site

    Birkerød,
    Denmark

    Site Not Available

  • 1235.5.45002 Boehringer Ingelheim Investigational Site

    Birkerød,
    Denmark

    Site Not Available

  • 1235.5.45005 Boehringer Ingelheim Investigational Site

    Haderslev,
    Denmark

    Site Not Available

  • 1235.5.45008 Boehringer Ingelheim Investigational Site

    Herning,
    Denmark

    Site Not Available

  • 1235.5.45009 Boehringer Ingelheim Investigational Site

    Hinnerup,
    Denmark

    Site Not Available

  • 1235.5.45001 Boehringer Ingelheim Investigational Site

    Rødovre,
    Denmark

    Site Not Available

  • 1235.5.45001 Boehringer Ingelheim Investigational Site

    Rødovre,
    Denmark

    Site Not Available

  • 1235.5.45006 Boehringer Ingelheim Investigational Site

    Rødovre,
    Denmark

    Site Not Available

  • 1235.5.45003 Boehringer Ingelheim Investigational Site

    Vaerløse,
    Denmark

    Site Not Available

  • 1235.5.45003 Boehringer Ingelheim Investigational Site

    Vaerløse,
    Denmark

    Site Not Available

  • 1235.5.45007 Boehringer Ingelheim Investigational Site

    Vildbjerg,
    Denmark

    Site Not Available

  • 1235.5.35003 Boehringer Ingelheim Investigational Site

    Joensuu,
    Finland

    Site Not Available

  • 1235.5.35004 Boehringer Ingelheim Investigational Site

    Joensuu,
    Finland

    Site Not Available

  • 1235.5.35001 Boehringer Ingelheim Investigational Site

    Turku,
    Finland

    Site Not Available

  • 1235.5.35002 Boehringer Ingelheim Investigational Site

    Turku,
    Finland

    Site Not Available

  • 1235.5.3301H Boehringer Ingelheim Investigational Site

    Aigrefeuille S/Maine,
    France

    Site Not Available

  • 1235.5.3306C Boehringer Ingelheim Investigational Site

    Angers,
    France

    Site Not Available

  • 1235.5.3309B Boehringer Ingelheim Investigational Site

    Angers,
    France

    Site Not Available

  • 1235.5.3309C Boehringer Ingelheim Investigational Site

    Angers,
    France

    Site Not Available

  • 1235.5.3309E Boehringer Ingelheim Investigational Site

    Angers,
    France

    Site Not Available

  • 1235.5.3309D Boehringer Ingelheim Investigational Site

    Avrille,
    France

    Site Not Available

  • 1235.5.3309A Boehringer Ingelheim Investigational Site

    Beaucouze,
    France

    Site Not Available

  • 1235.5.3305A Boehringer Ingelheim Investigational Site

    Bourg des cptes,
    France

    Site Not Available

  • 1235.5.3306D Boehringer Ingelheim Investigational Site

    Briollay,
    France

    Site Not Available

  • 1235.5.3308B Boehringer Ingelheim Investigational Site

    Cholet,
    France

    Site Not Available

  • 1235.5.3308C Boehringer Ingelheim Investigational Site

    Cholet,
    France

    Site Not Available

  • 1235.5.3308D Boehringer Ingelheim Investigational Site

    Cholet,
    France

    Site Not Available

  • 1235.5.3308F Boehringer Ingelheim Investigational Site

    Cholet,
    France

    Site Not Available

  • 1235.5.3302C Boehringer Ingelheim Investigational Site

    Garchizy,
    France

    Site Not Available

  • 1235.5.3303C Boehringer Ingelheim Investigational Site

    Grandchamps,
    France

    Site Not Available

  • 1235.5.3302D Boehringer Ingelheim Investigational Site

    Guerigny,
    France

    Site Not Available

  • 1235.5.3310A Boehringer Ingelheim Investigational Site

    Jarny,
    France

    Site Not Available

  • 1235.5.3301L Boehringer Ingelheim Investigational Site

    La Chapelle /s Erdre,
    France

    Site Not Available

  • 1235.5.3301J Boehringer Ingelheim Investigational Site

    La Chapelle sur Erdre,
    France

    Site Not Available

  • 1235.5.3304A Boehringer Ingelheim Investigational Site

    La Fresnais,
    France

    Site Not Available

  • 1235.5.3308E Boehringer Ingelheim Investigational Site

    La Jubaudière,
    France

    Site Not Available

  • 1235.5.3308E Boehringer Ingelheim Investigational Site

    La Jubaudière,
    France

    Site Not Available

  • 1235.5.3301G Boehringer Ingelheim Investigational Site

    La Montagne,
    France

    Site Not Available

  • 1235.5.3303B Boehringer Ingelheim Investigational Site

    Le Bono,
    France

    Site Not Available

  • 1235.5.3307D Boehringer Ingelheim Investigational Site

    Le Mesnil en Vallée,
    France

    Site Not Available

  • 1235.5.3307D Boehringer Ingelheim Investigational Site

    Le Mesnil en Vallée,
    France

    Site Not Available

  • 1235.5.3301E Boehringer Ingelheim Investigational Site

    Le Temple de Bretagne,
    France

    Site Not Available

  • 1235.5.3309F Boehringer Ingelheim Investigational Site

    Les Ponts de CE,
    France

    Site Not Available

  • 1235.5.3307G Boehringer Ingelheim Investigational Site

    Loudun,
    France

    Site Not Available

  • 1235.5.3305B Boehringer Ingelheim Investigational Site

    Louvigné le Bais,
    France

    Site Not Available

  • 1235.5.3305B Boehringer Ingelheim Investigational Site

    Louvigné le Bais,
    France

    Site Not Available

  • 1235.5.3307E Boehringer Ingelheim Investigational Site

    Mouliherne,
    France

    Site Not Available

  • 1235.5.3306A Boehringer Ingelheim Investigational Site

    Murs Erigne,
    France

    Site Not Available

  • 1235.5.3307A Boehringer Ingelheim Investigational Site

    Murs-Erigne,
    France

    Site Not Available

  • 1235.5.3301A Boehringer Ingelheim Investigational Site

    Nantes,
    France

    Site Not Available

  • 1235.5.3301B Boehringer Ingelheim Investigational Site

    Nantes,
    France

    Site Not Available

  • 1235.5.3301D Boehringer Ingelheim Investigational Site

    Nantes,
    France

    Site Not Available

  • 1235.5.3301M Boehringer Ingelheim Investigational Site

    Nantes,
    France

    Site Not Available

  • 1235.5.3302A Boehringer Ingelheim Investigational Site

    Nevers,
    France

    Site Not Available

  • 1235.5.3302F Boehringer Ingelheim Investigational Site

    Nevers,
    France

    Site Not Available

  • 1235.5.3301I Boehringer Ingelheim Investigational Site

    Nort sur Erdre,
    France

    Site Not Available

  • 1235.5.3301C Boehringer Ingelheim Investigational Site

    Orvault,
    France

    Site Not Available

  • 1235.5.3307F Boehringer Ingelheim Investigational Site

    Parcay les Pins,
    France

    Site Not Available

  • 1235.5.3307C Boehringer Ingelheim Investigational Site

    Saint Pierre Montlimard,
    France

    Site Not Available

  • 1235.5.3301N Boehringer Ingelheim Investigational Site

    Sautron,
    France

    Site Not Available

  • 1235.5.3306B Boehringer Ingelheim Investigational Site

    Segre,
    France

    Site Not Available

  • 1235.5.3301F Boehringer Ingelheim Investigational Site

    St Aubin les Châteaux,
    France

    Site Not Available

  • 1235.5.3301F Boehringer Ingelheim Investigational Site

    St Aubin les Châteaux,
    France

    Site Not Available

  • 1235.5.3306F Boehringer Ingelheim Investigational Site

    St Georges de Montaigu,
    France

    Site Not Available

  • 1235.5.3304B Boehringer Ingelheim Investigational Site

    St Ouen La Rouerie,
    France

    Site Not Available

  • 1235.5.3306E Boehringer Ingelheim Investigational Site

    Thouars,
    France

    Site Not Available

  • 1235.5.3304C Boehringer Ingelheim Investigational Site

    Tinténiac,
    France

    Site Not Available

  • 1235.5.3304C Boehringer Ingelheim Investigational Site

    Tinténiac,
    France

    Site Not Available

  • 1235.5.3303A Boehringer Ingelheim Investigational Site

    Vannes,
    France

    Site Not Available

  • 1235.5.3308A Boehringer Ingelheim Investigational Site

    Vihiers,
    France

    Site Not Available

  • 1235.5.82007 Boehringer Ingelheim Investigational Site

    Busan,
    Korea, Republic of

    Site Not Available

  • 1235.5.82001 Boehringer Ingelheim Investigational Site

    Daegu,
    Korea, Republic of

    Site Not Available

  • 1235.5.82006 Boehringer Ingelheim Investigational Site

    Daejon,
    Korea, Republic of

    Site Not Available

  • 1235.5.82004 Boehringer Ingelheim Investigational Site

    Gangwon-Do,
    Korea, Republic of

    Site Not Available

  • 1235.5.82008 Boehringer Ingelheim Investigational Site

    Gwangju,
    Korea, Republic of

    Site Not Available

  • 1235.5.82002 Boehringer Ingelheim Investigational Site

    Seoul,
    Korea, Republic of

    Site Not Available

  • 1235.5.82003 Boehringer Ingelheim Investigational Site

    Seoul,
    Korea, Republic of

    Site Not Available

  • 1235.5.82005 Boehringer Ingelheim Investigational Site

    Seoul,
    Korea, Republic of

    Site Not Available

  • 1235.5.31008 Boehringer Ingelheim Investigational Site

    Beerzerveld,
    Netherlands

    Site Not Available

  • 1235.5.31006 Boehringer Ingelheim Investigational Site

    Bennebroek,
    Netherlands

    Site Not Available

  • 1235.5.31004 Boehringer Ingelheim Investigational Site

    Hoogwoud,
    Netherlands

    Site Not Available

  • 1235.5.31003 Boehringer Ingelheim Investigational Site

    Musselkanaal,
    Netherlands

    Site Not Available

  • 1235.5.31007 Boehringer Ingelheim Investigational Site

    Nijverdal,
    Netherlands

    Site Not Available

  • 1235.5.31001 Boehringer Ingelheim Investigational Site

    Oude Pekela,
    Netherlands

    Site Not Available

  • 1235.5.31005 Boehringer Ingelheim Investigational Site

    Roelofarendsveen,
    Netherlands

    Site Not Available

  • 1235.5.31010 Boehringer Ingelheim Investigational Site

    Voerendaal,
    Netherlands

    Site Not Available

  • 1235.5.47002 Boehringer Ingelheim Investigational Site

    Bergen,
    Norway

    Site Not Available

  • 1235.5.47003 Boehringer Ingelheim Investigational Site

    Hamar,
    Norway

    Site Not Available

  • 1235.5.47004 Boehringer Ingelheim Investigational Site

    Oslo,
    Norway

    Site Not Available

  • 1235.5.47001 Boehringer Ingelheim Investigational Site

    Ã…lesund,
    Norway

    Site Not Available

  • 1235.5.47001 Boehringer Ingelheim Investigational Site

    Ålesund,
    Norway

    Site Not Available

  • 1235.5.63006 Boehringer Ingelheim Investigational Site

    Makati City,
    Philippines

    Site Not Available

  • 1235.5.63001 Boehringer Ingelheim Investigational Site

    Manila,
    Philippines

    Site Not Available

  • 1235.5.63002 Boehringer Ingelheim Investigational Site

    Manila,
    Philippines

    Site Not Available

  • 1235.5.63009 Boehringer Ingelheim Investigational Site

    Manila,
    Philippines

    Site Not Available

  • 1235.5.63008 Boehringer Ingelheim Investigational Site

    Pasay City,
    Philippines

    Site Not Available

  • 1235.5.63005 Boehringer Ingelheim Investigational Site

    Pasig City,
    Philippines

    Site Not Available

  • 1235.5.63003 Boehringer Ingelheim Investigational Site

    Quezon City,
    Philippines

    Site Not Available

  • 1235.5.63007 Boehringer Ingelheim Investigational Site

    Quezon City,
    Philippines

    Site Not Available

  • 1235.5.27003 Boehringer Ingelheim Investigational Site

    Boksburg,
    South Africa

    Site Not Available

  • 1235.5.27006 Boehringer Ingelheim Investigational Site

    Cape Town,
    South Africa

    Site Not Available

  • 1235.5.27009 Boehringer Ingelheim Investigational Site

    Cape Town,
    South Africa

    Site Not Available

  • 1235.5.27010 Boehringer Ingelheim Investigational Site

    Cape Town,
    South Africa

    Site Not Available

  • 1235.5.27004 Boehringer Ingelheim Investigational Site

    Durban,
    South Africa

    Site Not Available

  • 1235.5.27008 Boehringer Ingelheim Investigational Site

    Johannesburg,
    South Africa

    Site Not Available

  • 1235.5.27001 Boehringer Ingelheim Investigational Site

    Krugersdorp,
    South Africa

    Site Not Available

  • 1235.5.27005 Boehringer Ingelheim Investigational Site

    Lenasia,
    South Africa

    Site Not Available

  • 1235.5.27002 Boehringer Ingelheim Investigational Site

    Pretoria,
    South Africa

    Site Not Available

  • 1235.5.46003 Boehringer Ingelheim Investigational Site

    Göteborg,
    Sweden

    Site Not Available

  • 1235.5.46002 Boehringer Ingelheim Investigational Site

    Göteborg,
    Sweden

    Site Not Available

  • 1235.5.46003 Boehringer Ingelheim Investigational Site

    Göteborg,
    Sweden

    Site Not Available

  • 1235.5.46005 Boehringer Ingelheim Investigational Site

    Luleå,
    Sweden

    Site Not Available

  • 1235.5.46005 Boehringer Ingelheim Investigational Site

    Luleå,
    Sweden

    Site Not Available

  • 1235.5.46004 Boehringer Ingelheim Investigational Site

    Rättvik,
    Sweden

    Site Not Available

  • 1235.5.46004 Boehringer Ingelheim Investigational Site

    Rättvik,
    Sweden

    Site Not Available

  • 1235.5.46001 Boehringer Ingelheim Investigational Site

    Stockholm,
    Sweden

    Site Not Available

  • 1235.5.88605 Boehringer Ingelheim Investigational Site

    Changhua,
    Taiwan

    Site Not Available

  • 1235.5.88608 Boehringer Ingelheim Investigational Site

    Hualien City,
    Taiwan

    Site Not Available

  • 1235.5.88601 Boehringer Ingelheim Investigational Site

    Kaohsiung,
    Taiwan

    Site Not Available

  • 1235.5.88603 Boehringer Ingelheim Investigational Site

    Taichung,
    Taiwan

    Site Not Available

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