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

NCT00558428 | Completed Phase 3 Results

• 2 other identifiers: 1235.5EUDRACT2007-002409-36
• Study Type: interventional
• Target: 1,098
• Locations: 12 countries
• Sites: 129

Brief 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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Trough Seated Diastolic Blood Pressure (DBP)

  Change from baseline to the end of study in trough DBP

  End of study (8 weeks or last value on treatment)

• Number of Patients With Oedema

  Patients from the treated set who experienced at least one case of general oedema.

  During randomised treatment period (8 weeks was the planned end of treatment, some of the measurements analysed as end of study can be at 4 weeks or at any point on randomised treatment)

Secondary Outcomes (6)

• Change From Baseline in Trough Seated Systolic Blood Pressure (SBP)

  End of study (8 weeks or last value on treatment)

• Trough Seated Diastolic Blood Pressure Control

  End of study (8 weeks or last value on treatment)

• Trough Seated DBP Response

  End of study (8 weeks or last value on treatment)

• Trough Seated SBP Control

  End of study (8 weeks or last value on treatment)

• Trough Seated SBP Response

  End of study (8 weeks or last value on treatment)

Interventions

fixed dose combination of telmisartan+amlodipine DRUG

amlodipine DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients aged at least 18 years at the date of signing the consent form
• diagnosis of essential hypertension and blood pressure not adequately controlled before enrolment in the study
• failure to respond adequately to six weeks treatment with amlodipine 5 mg monotherapy
• able to stop any current antihypertensive therapy without unacceptable risk to the patient (Investigator's decision)
• willing and able to provide written informed consent (in accordance with Good Clinical Practice and local legislation).

You may not qualify if:

• 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.
• known or suspected secondary hypertension
• 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)
• any clinically significant hepatic impairment (e.g. clinically significant cholestasis, biliary obstructive disorder or hepatic insufficiency)
• 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)
• bilateral renal artery stenosis or renal artery stenosis in a solitary kidney or post-renal transplant
• clinically relevant hyperkalaemia
• uncorrected volume or sodium depletion.
• primary aldosteronism.
• hereditary fructose or lactose intolerance

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (129)

1235.5.32004 Boehringer Ingelheim Investigational Site

Aywaille, Belgium

Location

1235.5.32001 Boehringer Ingelheim Investigational Site

Brussels, Belgium

Location

1235.5.32010 Boehringer Ingelheim Investigational Site

Gozée, Belgium

Location

1235.5.32008 Boehringer Ingelheim Investigational Site

Linkebeek, Belgium

Location

1235.5.32003 Boehringer Ingelheim Investigational Site

Mol, Belgium

Location

1235.5.32007 Boehringer Ingelheim Investigational Site

Natoye, Belgium

Location

1235.5.32009 Boehringer Ingelheim Investigational Site

Tavier, Belgium

Location

1235.5.32002 Boehringer Ingelheim Investigational Site

Tienen-Kumtich, Belgium

Location

1235.5.32005 Boehringer Ingelheim Investigational Site

Turnhout, Belgium

Location

1235.5.20001 Boehringer Ingelheim Investigational Site

Coquitlam, British Columbia, Canada

Location

1235.5.20011 Boehringer Ingelheim Investigational Site

Vancouver, British Columbia, Canada

Location

1235.5.20007 Boehringer Ingelheim Investigational Site

Bay Roberts, Newfoundland and Labrador, Canada

Location

1235.5.20005 Boehringer Ingelheim Investigational Site

Mount Pearl, Newfoundland and Labrador, Canada

Location

1235.5.20008 Boehringer Ingelheim Investigational Site

St. John's, Newfoundland and Labrador, Canada

Location

1235.5.20013 Boehringer Ingelheim Investigational Site

Corunna, Ontario, Canada

Location

1235.5.20014 Boehringer Ingelheim Investigational Site

Etobicoke, Ontario, Canada

Location

1235.5.20010 Boehringer Ingelheim Investigational Site

Hamilton, Ontario, Canada

Location

1235.5.20012 Boehringer Ingelheim Investigational Site

London, Ontario, Canada

Location

1235.5.20009 Boehringer Ingelheim Investigational Site

Ottawa, Ontario, Canada

Location

1235.5.20006 Boehringer Ingelheim Investigational Site

Sarnia, Ontario, Canada

Location

1235.5.20003 Boehringer Ingelheim Investigational Site

Sainte-Foy, Quebec, Canada

Location

1235.5.45002 Boehringer Ingelheim Investigational Site

Birkerød, Denmark

Location

1235.5.45005 Boehringer Ingelheim Investigational Site

Haderslev, Denmark

Location

1235.5.45008 Boehringer Ingelheim Investigational Site

Herning, Denmark

Location

1235.5.45009 Boehringer Ingelheim Investigational Site

Hinnerup, Denmark

Location

1235.5.45001 Boehringer Ingelheim Investigational Site

Rødovre Municipality, Denmark

Location

1235.5.45006 Boehringer Ingelheim Investigational Site

Rødovre Municipality, Denmark

Location

1235.5.45003 Boehringer Ingelheim Investigational Site

Vaerløse, Denmark

Location

1235.5.45007 Boehringer Ingelheim Investigational Site

Vildbjerg, Denmark

Location

1235.5.35003 Boehringer Ingelheim Investigational Site

Joensuu, Finland

Location

1235.5.35004 Boehringer Ingelheim Investigational Site

Joensuu, Finland

Location

1235.5.35001 Boehringer Ingelheim Investigational Site

Turku, Finland

Location

1235.5.35002 Boehringer Ingelheim Investigational Site

Turku, Finland

Location

1235.5.3301H Boehringer Ingelheim Investigational Site

Aigrefeuille S/Maine, France

Location

1235.5.3306C Boehringer Ingelheim Investigational Site

Angers, France

Location

1235.5.3309B Boehringer Ingelheim Investigational Site

Angers, France

Location

1235.5.3309C Boehringer Ingelheim Investigational Site

Angers, France

Location

1235.5.3309E Boehringer Ingelheim Investigational Site

Angers, France

Location

1235.5.3309D Boehringer Ingelheim Investigational Site

Avrillé, France

Location

1235.5.3309A Boehringer Ingelheim Investigational Site

Beaucouzé, France

Location

1235.5.3303B Boehringer Ingelheim Investigational Site

Bono, France

Location

1235.5.3305A Boehringer Ingelheim Investigational Site

Bourg Des Cptes, France

Location

1235.5.3306D Boehringer Ingelheim Investigational Site

Briollay, France

Location

1235.5.3308B Boehringer Ingelheim Investigational Site

Cholet, France

Location

1235.5.3308C Boehringer Ingelheim Investigational Site

Cholet, France

Location

1235.5.3308D Boehringer Ingelheim Investigational Site

Cholet, France

Location

1235.5.3308F Boehringer Ingelheim Investigational Site

Cholet, France

Location

1235.5.3302C Boehringer Ingelheim Investigational Site

Garchizy, France

Location

1235.5.3303C Boehringer Ingelheim Investigational Site

Grandchamps, France

Location

1235.5.3302D Boehringer Ingelheim Investigational Site

Guérigny, France

Location

1235.5.3310A Boehringer Ingelheim Investigational Site

Jarny, France

Location

1235.5.3301L Boehringer Ingelheim Investigational Site

La Chapelle /s Erdre, France

Location

1235.5.3301J Boehringer Ingelheim Investigational Site

La Chapelle-sur-Erdre, France

Location

1235.5.3304A Boehringer Ingelheim Investigational Site

La Fresnais, France

Location

1235.5.3308E Boehringer Ingelheim Investigational Site

La Jubaudière, France

Location

1235.5.3301G Boehringer Ingelheim Investigational Site

La Montagne, France

Location

1235.5.3307D Boehringer Ingelheim Investigational Site

Le Mesnil-en-Vallée, France

Location

1235.5.3301E Boehringer Ingelheim Investigational Site

Le Temple-de-Bretagne, France

Location

1235.5.3309F Boehringer Ingelheim Investigational Site

Les Ponts-de-Cé, France

Location

1235.5.3307G Boehringer Ingelheim Investigational Site

Loudun, France

Location

1235.5.3305B Boehringer Ingelheim Investigational Site

Louvigné Le Bais, France

Location

1235.5.3307E Boehringer Ingelheim Investigational Site

Mouliherne, France

Location

1235.5.3306A Boehringer Ingelheim Investigational Site

Mûrs-Erigné, France

Location

1235.5.3307A Boehringer Ingelheim Investigational Site

Mûrs-Erigné, France

Location

1235.5.3301A Boehringer Ingelheim Investigational Site

Nantes, France

Location

1235.5.3301B Boehringer Ingelheim Investigational Site

Nantes, France

Location

1235.5.3301D Boehringer Ingelheim Investigational Site

Nantes, France

Location

1235.5.3301M Boehringer Ingelheim Investigational Site

Nantes, France

Location

1235.5.3302A Boehringer Ingelheim Investigational Site

Nevers, France

Location

1235.5.3302F Boehringer Ingelheim Investigational Site

Nevers, France

Location

1235.5.3301I Boehringer Ingelheim Investigational Site

Nort-sur-Erdre, France

Location

1235.5.3301C Boehringer Ingelheim Investigational Site

Orvault, France

Location

1235.5.3307F Boehringer Ingelheim Investigational Site

Parçay-les-Pins, France

Location

1235.5.3301F Boehringer Ingelheim Investigational Site

Saint Aubin Les Châteaux, France

Location

1235.5.3306F Boehringer Ingelheim Investigational Site

Saint-Georges-de-Montaigu, France

Location

1235.5.3304B Boehringer Ingelheim Investigational Site

Saint-Ouen-la-Rouërie, France

Location

1235.5.3307C Boehringer Ingelheim Investigational Site

Saint-Pierre-Montlimart, France

Location

1235.5.3301N Boehringer Ingelheim Investigational Site

Sautron, France

Location

1235.5.3306B Boehringer Ingelheim Investigational Site

Segré, France

Location

1235.5.3306E Boehringer Ingelheim Investigational Site

Thouars, France

Location

1235.5.3304C Boehringer Ingelheim Investigational Site

Tinténiac, France

Location

1235.5.3303A Boehringer Ingelheim Investigational Site

Vannes, France

Location

1235.5.3308A Boehringer Ingelheim Investigational Site

Vihiers, France

Location

1235.5.31008 Boehringer Ingelheim Investigational Site

Beerzerveld, Netherlands

Location

1235.5.31006 Boehringer Ingelheim Investigational Site

Bennebroek, Netherlands

Location

1235.5.31004 Boehringer Ingelheim Investigational Site

Hoogwoud, Netherlands

Location

1235.5.31003 Boehringer Ingelheim Investigational Site

Musselkanaal, Netherlands

Location

1235.5.31007 Boehringer Ingelheim Investigational Site

Nijverdal, Netherlands

Location

1235.5.31001 Boehringer Ingelheim Investigational Site

Oude Pekela, Netherlands

Location

1235.5.31005 Boehringer Ingelheim Investigational Site

Roelofarendsveen, Netherlands

Location

1235.5.31010 Boehringer Ingelheim Investigational Site

Voerendaal, Netherlands

Location

1235.5.47001 Boehringer Ingelheim Investigational Site

Ålesund, Norway

Location

1235.5.47002 Boehringer Ingelheim Investigational Site

Bergen, Norway

Location

1235.5.47003 Boehringer Ingelheim Investigational Site

Hamar, Norway

Location

1235.5.47004 Boehringer Ingelheim Investigational Site

Oslo, Norway

Location

1235.5.63006 Boehringer Ingelheim Investigational Site

Makati City, Philippines

Location

1235.5.63001 Boehringer Ingelheim Investigational Site

Manila, Philippines

Location

1235.5.63002 Boehringer Ingelheim Investigational Site

Manila, Philippines

Location

1235.5.63009 Boehringer Ingelheim Investigational Site

Manila, Philippines

Location

1235.5.63008 Boehringer Ingelheim Investigational Site

Pasay, Philippines

Location

1235.5.63005 Boehringer Ingelheim Investigational Site

Pasig, Philippines

Location

1235.5.63003 Boehringer Ingelheim Investigational Site

Quezon City, Philippines

Location

1235.5.63007 Boehringer Ingelheim Investigational Site

Quezon City, Philippines

Location

1235.5.27003 Boehringer Ingelheim Investigational Site

Boksburg, South Africa

Location

1235.5.27006 Boehringer Ingelheim Investigational Site

Cape Town, South Africa

Location

1235.5.27009 Boehringer Ingelheim Investigational Site

Cape Town, South Africa

Location

1235.5.27010 Boehringer Ingelheim Investigational Site

Cape Town, South Africa

Location

1235.5.27004 Boehringer Ingelheim Investigational Site

Durban, South Africa

Location

1235.5.27008 Boehringer Ingelheim Investigational Site

Johannesburg, South Africa

Location

1235.5.27001 Boehringer Ingelheim Investigational Site

Krugersdorp, South Africa

Location

1235.5.27005 Boehringer Ingelheim Investigational Site

Lenasia, South Africa

Location

1235.5.27002 Boehringer Ingelheim Investigational Site

Pretoria, South Africa

Location

1235.5.82007 Boehringer Ingelheim Investigational Site

Busan, South Korea

Location

1235.5.82001 Boehringer Ingelheim Investigational Site

Daegu, South Korea

Location

1235.5.82006 Boehringer Ingelheim Investigational Site

Daejeon, South Korea

Location

1235.5.82004 Boehringer Ingelheim Investigational Site

Gangwon-Do, South Korea

Location

1235.5.82008 Boehringer Ingelheim Investigational Site

Gwangju, South Korea

Location

1235.5.82002 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

1235.5.82003 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

1235.5.82005 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

1235.5.46002 Boehringer Ingelheim Investigational Site

Gothenburg, Sweden

Location

1235.5.46003 Boehringer Ingelheim Investigational Site

Gothenburg, Sweden

Location

1235.5.46005 Boehringer Ingelheim Investigational Site

Luleå, Sweden

Location

1235.5.46004 Boehringer Ingelheim Investigational Site

Rättvik, Sweden

Location

1235.5.46001 Boehringer Ingelheim Investigational Site

Stockholm, Sweden

Location

1235.5.88605 Boehringer Ingelheim Investigational Site

Changhua, Taiwan

Location

1235.5.88608 Boehringer Ingelheim Investigational Site

Hualien City, Taiwan

Location

1235.5.88601 Boehringer Ingelheim Investigational Site

Kaohsiung City, Taiwan

Location

1235.5.88603 Boehringer Ingelheim Investigational Site

Taichung, Taiwan

Location

Related Links

• Related Info

MeSH Terms

Conditions

Hypertension

Interventions

Amlodipine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 29, 2007
• First Posted: November 15, 2007
• Study Start: October 1, 2007
• Primary Completion: September 1, 2008
• Last Updated: June 27, 2014
• Results First Posted: December 15, 2009

Record last verified: 2014-05

Locations

PH (8); SE (5); TW (4); NL (8); CA (12); FI (4); BE (9); ZA (9); KR (8); FR (50); NO (4); DK (8)