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

NCT ID: NCT00558428

Last Updated: 2014-06-27

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1098 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Hypertension

Study Design

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Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Interventions

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fixed dose combination of telmisartan+amlodipine

Intervention Type DRUG

amlodipine

Intervention Type DRUG

Eligibility Criteria

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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 controlled before 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 the patient (Investigator's decision)
5. willing and able to provide written informed consent (in accordance with Good Clinical Practice and local legislation).

Exclusion Criteria

1. are not practising acceptable means of birth control or do not plan to continue using acceptable means of birth control throughout the study and do not agree to submit to pregnancy testing during participation in the trial. Acceptable methods of birth control 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 diastolic blood pressure (DBP) over 120 mmHg at Visit 1 or 2 or mean seated SBP over 180 mmHg and/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 significant cholestasis, biliary obstructive disorder or hepatic insufficiency)
5. severe renal impairment (e.g. serum creatinine \>3.0 mg/dL or \>265 mcmol/L, known creatinine clearance \<30mL/min or clinical markers of severe renal impairment)
6. bilateral renal artery stenosis or renal artery stenosis in a solitary kidney or post-renal transplant
7. clinically relevant hyperkalaemia
8. uncorrected volume or sodium depletion.
9. primary aldosteronism.
10. hereditary fructose or lactose intolerance
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Boehringer Ingelheim

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1235.5.32004 Boehringer Ingelheim Investigational Site

Aywaille, , Belgium

Site Status

1235.5.32001 Boehringer Ingelheim Investigational Site

Brussels, , Belgium

Site Status

1235.5.32010 Boehringer Ingelheim Investigational Site

Gozée, , Belgium

Site Status

1235.5.32008 Boehringer Ingelheim Investigational Site

Linkebeek, , Belgium

Site Status

1235.5.32003 Boehringer Ingelheim Investigational Site

Mol, , Belgium

Site Status

1235.5.32007 Boehringer Ingelheim Investigational Site

Natoye, , Belgium

Site Status

1235.5.32009 Boehringer Ingelheim Investigational Site

Tavier, , Belgium

Site Status

1235.5.32002 Boehringer Ingelheim Investigational Site

Tienen-Kumtich, , Belgium

Site Status

1235.5.32005 Boehringer Ingelheim Investigational Site

Turnhout, , Belgium

Site Status

1235.5.20001 Boehringer Ingelheim Investigational Site

Coquitlam, British Columbia, Canada

Site Status

1235.5.20011 Boehringer Ingelheim Investigational Site

Vancouver, British Columbia, Canada

Site Status

1235.5.20007 Boehringer Ingelheim Investigational Site

Bay Roberts, Newfoundland and Labrador, Canada

Site Status

1235.5.20005 Boehringer Ingelheim Investigational Site

Mount Pearl, Newfoundland and Labrador, Canada

Site Status

1235.5.20008 Boehringer Ingelheim Investigational Site

St. John's, Newfoundland and Labrador, Canada

Site Status

1235.5.20013 Boehringer Ingelheim Investigational Site

Corunna, Ontario, Canada

Site Status

1235.5.20014 Boehringer Ingelheim Investigational Site

Etobicoke, Ontario, Canada

Site Status

1235.5.20010 Boehringer Ingelheim Investigational Site

Hamilton, Ontario, Canada

Site Status

1235.5.20012 Boehringer Ingelheim Investigational Site

London, Ontario, Canada

Site Status

1235.5.20009 Boehringer Ingelheim Investigational Site

Ottawa, Ontario, Canada

Site Status

1235.5.20006 Boehringer Ingelheim Investigational Site

Sarnia, Ontario, Canada

Site Status

1235.5.20003 Boehringer Ingelheim Investigational Site

Sainte-Foy, Quebec, Canada

Site Status

1235.5.45002 Boehringer Ingelheim Investigational Site

Birkerød, , Denmark

Site Status

1235.5.45005 Boehringer Ingelheim Investigational Site

Haderslev, , Denmark

Site Status

1235.5.45008 Boehringer Ingelheim Investigational Site

Herning, , Denmark

Site Status

1235.5.45009 Boehringer Ingelheim Investigational Site

Hinnerup, , Denmark

Site Status

1235.5.45001 Boehringer Ingelheim Investigational Site

Rødovre Municipality, , Denmark

Site Status

1235.5.45006 Boehringer Ingelheim Investigational Site

Rødovre Municipality, , Denmark

Site Status

1235.5.45003 Boehringer Ingelheim Investigational Site

Vaerløse, , Denmark

Site Status

1235.5.45007 Boehringer Ingelheim Investigational Site

Vildbjerg, , Denmark

Site Status

1235.5.35003 Boehringer Ingelheim Investigational Site

Joensuu, , Finland

Site Status

1235.5.35004 Boehringer Ingelheim Investigational Site

Joensuu, , Finland

Site Status

1235.5.35001 Boehringer Ingelheim Investigational Site

Turku, , Finland

Site Status

1235.5.35002 Boehringer Ingelheim Investigational Site

Turku, , Finland

Site Status

1235.5.3301H Boehringer Ingelheim Investigational Site

Aigrefeuille S/Maine, , France

Site Status

1235.5.3306C Boehringer Ingelheim Investigational Site

Angers, , France

Site Status

1235.5.3309B Boehringer Ingelheim Investigational Site

Angers, , France

Site Status

1235.5.3309C Boehringer Ingelheim Investigational Site

Angers, , France

Site Status

1235.5.3309E Boehringer Ingelheim Investigational Site

Angers, , France

Site Status

1235.5.3309D Boehringer Ingelheim Investigational Site

Avrillé, , France

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1235.5.3309A Boehringer Ingelheim Investigational Site

Beaucouzé, , France

Site Status

1235.5.3303B Boehringer Ingelheim Investigational Site

Bono, , France

Site Status

1235.5.3305A Boehringer Ingelheim Investigational Site

Bourg Des Cptes, , France

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1235.5.3306D Boehringer Ingelheim Investigational Site

Briollay, , France

Site Status

1235.5.3308B Boehringer Ingelheim Investigational Site

Cholet, , France

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1235.5.3308C Boehringer Ingelheim Investigational Site

Cholet, , France

Site Status

1235.5.3308D Boehringer Ingelheim Investigational Site

Cholet, , France

Site Status

1235.5.3308F Boehringer Ingelheim Investigational Site

Cholet, , France

Site Status

1235.5.3302C Boehringer Ingelheim Investigational Site

Garchizy, , France

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1235.5.3303C Boehringer Ingelheim Investigational Site

Grandchamps, , France

Site Status

1235.5.3302D Boehringer Ingelheim Investigational Site

Guérigny, , France

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1235.5.3310A Boehringer Ingelheim Investigational Site

Jarny, , France

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1235.5.3301L Boehringer Ingelheim Investigational Site

La Chapelle /s Erdre, , France

Site Status

1235.5.3301J Boehringer Ingelheim Investigational Site

La Chapelle-sur-Erdre, , France

Site Status

1235.5.3304A Boehringer Ingelheim Investigational Site

La Fresnais, , France

Site Status

1235.5.3308E Boehringer Ingelheim Investigational Site

La Jubaudière, , France

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1235.5.3301G Boehringer Ingelheim Investigational Site

La Montagne, , France

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1235.5.3307D Boehringer Ingelheim Investigational Site

Le Mesnil-en-Vallée, , France

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1235.5.3301E Boehringer Ingelheim Investigational Site

Le Temple-de-Bretagne, , France

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1235.5.3309F Boehringer Ingelheim Investigational Site

Les Ponts-de-Cé, , France

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1235.5.3307G Boehringer Ingelheim Investigational Site

Loudun, , France

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1235.5.3305B Boehringer Ingelheim Investigational Site

Louvigné Le Bais, , France

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1235.5.3307E Boehringer Ingelheim Investigational Site

Mouliherne, , France

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1235.5.3306A Boehringer Ingelheim Investigational Site

Mûrs-Erigné, , France

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1235.5.3307A Boehringer Ingelheim Investigational Site

Mûrs-Erigné, , France

Site Status

1235.5.3301A Boehringer Ingelheim Investigational Site

Nantes, , France

Site Status

1235.5.3301B Boehringer Ingelheim Investigational Site

Nantes, , France

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1235.5.3301D Boehringer Ingelheim Investigational Site

Nantes, , France

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1235.5.3301M Boehringer Ingelheim Investigational Site

Nantes, , France

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1235.5.3302A Boehringer Ingelheim Investigational Site

Nevers, , France

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1235.5.3302F Boehringer Ingelheim Investigational Site

Nevers, , France

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1235.5.3301I Boehringer Ingelheim Investigational Site

Nort-sur-Erdre, , France

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1235.5.3301C Boehringer Ingelheim Investigational Site

Orvault, , France

Site Status

1235.5.3307F Boehringer Ingelheim Investigational Site

Parçay-les-Pins, , France

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1235.5.3301F Boehringer Ingelheim Investigational Site

Saint Aubin Les Châteaux, , France

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1235.5.3306F Boehringer Ingelheim Investigational Site

Saint-Georges-de-Montaigu, , France

Site Status

1235.5.3304B Boehringer Ingelheim Investigational Site

Saint-Ouen-la-Rouërie, , France

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1235.5.3307C Boehringer Ingelheim Investigational Site

Saint-Pierre-Montlimart, , France

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1235.5.3301N Boehringer Ingelheim Investigational Site

Sautron, , France

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1235.5.3306B Boehringer Ingelheim Investigational Site

Segré, , France

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1235.5.3306E Boehringer Ingelheim Investigational Site

Thouars, , France

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1235.5.3304C Boehringer Ingelheim Investigational Site

Tinténiac, , France

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1235.5.3303A Boehringer Ingelheim Investigational Site

Vannes, , France

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1235.5.3308A Boehringer Ingelheim Investigational Site

Vihiers, , France

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1235.5.31008 Boehringer Ingelheim Investigational Site

Beerzerveld, , Netherlands

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1235.5.31006 Boehringer Ingelheim Investigational Site

Bennebroek, , Netherlands

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1235.5.31004 Boehringer Ingelheim Investigational Site

Hoogwoud, , Netherlands

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1235.5.31003 Boehringer Ingelheim Investigational Site

Musselkanaal, , Netherlands

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1235.5.31007 Boehringer Ingelheim Investigational Site

Nijverdal, , Netherlands

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1235.5.31001 Boehringer Ingelheim Investigational Site

Oude Pekela, , Netherlands

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1235.5.31005 Boehringer Ingelheim Investigational Site

Roelofarendsveen, , Netherlands

Site Status

1235.5.31010 Boehringer Ingelheim Investigational Site

Voerendaal, , Netherlands

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1235.5.47001 Boehringer Ingelheim Investigational Site

Ålesund, , Norway

Site Status

1235.5.47002 Boehringer Ingelheim Investigational Site

Bergen, , Norway

Site Status

1235.5.47003 Boehringer Ingelheim Investigational Site

Hamar, , Norway

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1235.5.47004 Boehringer Ingelheim Investigational Site

Oslo, , Norway

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1235.5.63006 Boehringer Ingelheim Investigational Site

Makati City, , Philippines

Site Status

1235.5.63001 Boehringer Ingelheim Investigational Site

Manila, , Philippines

Site Status

1235.5.63002 Boehringer Ingelheim Investigational Site

Manila, , Philippines

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1235.5.63009 Boehringer Ingelheim Investigational Site

Manila, , Philippines

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1235.5.63008 Boehringer Ingelheim Investigational Site

Pasay, , Philippines

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1235.5.63005 Boehringer Ingelheim Investigational Site

Pasig, , Philippines

Site Status

1235.5.63003 Boehringer Ingelheim Investigational Site

Quezon City, , Philippines

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1235.5.63007 Boehringer Ingelheim Investigational Site

Quezon City, , Philippines

Site Status

1235.5.27003 Boehringer Ingelheim Investigational Site

Boksburg, , South Africa

Site Status

1235.5.27006 Boehringer Ingelheim Investigational Site

Cape Town, , South Africa

Site Status

1235.5.27009 Boehringer Ingelheim Investigational Site

Cape Town, , South Africa

Site Status

1235.5.27010 Boehringer Ingelheim Investigational Site

Cape Town, , South Africa

Site Status

1235.5.27004 Boehringer Ingelheim Investigational Site

Durban, , South Africa

Site Status

1235.5.27008 Boehringer Ingelheim Investigational Site

Johannesburg, , South Africa

Site Status

1235.5.27001 Boehringer Ingelheim Investigational Site

Krugersdorp, , South Africa

Site Status

1235.5.27005 Boehringer Ingelheim Investigational Site

Lenasia, , South Africa

Site Status

1235.5.27002 Boehringer Ingelheim Investigational Site

Pretoria, , South Africa

Site Status

1235.5.82007 Boehringer Ingelheim Investigational Site

Busan, , South Korea

Site Status

1235.5.82001 Boehringer Ingelheim Investigational Site

Daegu, , South Korea

Site Status

1235.5.82006 Boehringer Ingelheim Investigational Site

Daejeon, , South Korea

Site Status

1235.5.82004 Boehringer Ingelheim Investigational Site

Gangwon-Do, , South Korea

Site Status

1235.5.82008 Boehringer Ingelheim Investigational Site

Gwangju, , South Korea

Site Status

1235.5.82002 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

Site Status

1235.5.82003 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

Site Status

1235.5.82005 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

Site Status

1235.5.46002 Boehringer Ingelheim Investigational Site

Gothenburg, , Sweden

Site Status

1235.5.46003 Boehringer Ingelheim Investigational Site

Gothenburg, , Sweden

Site Status

1235.5.46005 Boehringer Ingelheim Investigational Site

Luleå, , Sweden

Site Status

1235.5.46004 Boehringer Ingelheim Investigational Site

Rättvik, , Sweden

Site Status

1235.5.46001 Boehringer Ingelheim Investigational Site

Stockholm, , Sweden

Site Status

1235.5.88605 Boehringer Ingelheim Investigational Site

Changhua, , Taiwan

Site Status

1235.5.88608 Boehringer Ingelheim Investigational Site

Hualien City, , Taiwan

Site Status

1235.5.88601 Boehringer Ingelheim Investigational Site

Kaohsiung City, , Taiwan

Site Status

1235.5.88603 Boehringer Ingelheim Investigational Site

Taichung, , Taiwan

Site Status

Countries

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Belgium Canada Denmark Finland France Netherlands Norway Philippines South Africa South Korea Sweden Taiwan

Related Links

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http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1235/1235.5_Literature.pdf

Related Info

Other Identifiers

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EUDRACT2007-002409-36

Identifier Type: -

Identifier Source: secondary_id

1235.5

Identifier Type: -

Identifier Source: org_study_id

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