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Open Label Study Telmisartan and Amlodipine in Hypertension

NCT ID: NCT00614380

Last Updated: 2014-02-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

976 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Brief Summary

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The primary objective of this trial is to assess the efficacy and safety of the fixed dose combinations telmisartan 40 mg / amlodipine 5 mg (T40/A5) or telmisartan 80 mg / amlodipine 5 mg (T80/A5) during long-term open-label treatment.

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Detailed Description

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Conditions

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Hypertension

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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telmisartan/amlodipine 40/5 mg fixed combination

Intervention Type DRUG

telmisartan/amlodipine 80/5 mg fixed combination

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. patients aged at least 18 years
2. diagnosis of essential hypertension and blood pressure not adequately controlled before enrolment in the preceding trial.
3. failure to respond to six weeks treatment with Amlodipine 5 mg in the run-in period of the preceding trial.

Exclusion Criteria

1. pre-menopausal women who are not surgically sterile; or are nursing or pregnant; or are not practising acceptable means of birth control or do not plan to continue using acceptable means of birth control throughout the study
2. development of any medical condition in the preceding trial that in the investigator's opinion could be worsened by treatment with either Telmisartan 40 mg/Amlodipine 5 mg or Telmisartan 80 mg/Amlodipine 5 mg
3. discontinuation from the preceding trial because of any adverse event or any other reason
4. known or suspected secondary hypertension
5. mean seated Systolic Blood Pressure =\> 180 mmHg and/or mean seated Diastolic Blood Pressure =\> 120 mmHg at any visit
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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1235.7.32004 Boehringer Ingelheim Investigational Site

Aywaille, , Belgium

Site Status

1235.7.32010 Boehringer Ingelheim Investigational Site

Gozée, , Belgium

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1235.7.32008 Boehringer Ingelheim Investigational Site

Linkebeek, , Belgium

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1235.7.32003 Boehringer Ingelheim Investigational Site

Mol, , Belgium

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1235.7.32007 Boehringer Ingelheim Investigational Site

Natoye, , Belgium

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1235.7.32002 Boehringer Ingelheim Investigational Site

Tienen, , Belgium

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1235.7.32005 Boehringer Ingelheim Investigational Site

Turnhout, , Belgium

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1235.7.20001 Boehringer Ingelheim Investigational Site

Coquitlam, British Columbia, Canada

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1235.7.20011 Boehringer Ingelheim Investigational Site

Vancouver, British Columbia, Canada

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1235.7.20007 Boehringer Ingelheim Investigational Site

Bay Roberts, Newfoundland and Labrador, Canada

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1235.7.20005 Boehringer Ingelheim Investigational Site

Mount Pearl, Newfoundland and Labrador, Canada

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1235.7.20008 Boehringer Ingelheim Investigational Site

St. John's, Newfoundland and Labrador, Canada

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1235.7.20013 Boehringer Ingelheim Investigational Site

Corunna, Ontario, Canada

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1235.7.20014 Boehringer Ingelheim Investigational Site

Etobicoke, Ontario, Canada

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1235.7.20010 Boehringer Ingelheim Investigational Site

Hamilton, Ontario, Canada

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1235.7.20012 Boehringer Ingelheim Investigational Site

London, Ontario, Canada

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1235.7.20009 Boehringer Ingelheim Investigational Site

Ottawa, Ontario, Canada

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1235.7.20006 Boehringer Ingelheim Investigational Site

Sarnia, Ontario, Canada

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1235.7.20003 Boehringer Ingelheim Investigational Site

Sainte-Foy, Quebec, Canada

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1235.7.45002 Boehringer Ingelheim Investigational Site

Birkerød, , Denmark

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1235.7.45005 Boehringer Ingelheim Investigational Site

Haderslev, , Denmark

Site Status

1235.7.45008 Boehringer Ingelheim Investigational Site

Herning, , Denmark

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1235.7.45009 Boehringer Ingelheim Investigational Site

Hinnerup, , Denmark

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1235.7.45001 Boehringer Ingelheim Investigational Site

Rødovre Municipality, , Denmark

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1235.7.45006 Boehringer Ingelheim Investigational Site

Rødovre Municipality, , Denmark

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1235.7.45003 Boehringer Ingelheim Investigational Site

Vaerløse, , Denmark

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1235.7.45007 Boehringer Ingelheim Investigational Site

Vildbjerg, , Denmark

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1235.7.35003 Boehringer Ingelheim Investigational Site

Joensuu, , Finland

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1235.7.35004 Boehringer Ingelheim Investigational Site

Joensuu, , Finland

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1235.7.35001 Boehringer Ingelheim Investigational Site

Turku, , Finland

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1235.7.35002 Boehringer Ingelheim Investigational Site

Turku, , Finland

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1235.7.3301H Boehringer Ingelheim Investigational Site

Aigrefeuille S/Maine, , France

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1235.7.3306C Boehringer Ingelheim Investigational Site

Angers, , France

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1235.7.3309B Boehringer Ingelheim Investigational Site

Angers, , France

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1235.7.3309C Boehringer Ingelheim Investigational Site

Angers, , France

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1235.7.3309E Boehringer Ingelheim Investigational Site

Angers, , France

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1235.7.3309D Boehringer Ingelheim Investigational Site

Avrillé, , France

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1235.7.3309A Boehringer Ingelheim Investigational Site

Beaucouzé, , France

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1235.7.3305A Boehringer Ingelheim Investigational Site

Bourg Des Cptes, , France

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1235.7.3306D Boehringer Ingelheim Investigational Site

Briollay, , France

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1235.7.3308B Boehringer Ingelheim Investigational Site

Cholet, , France

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1235.7.3308F Boehringer Ingelheim Investigational Site

Cholet, , France

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1235.7.3302C Boehringer Ingelheim Investigational Site

Garchizy, , France

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1235.7.3303C Boehringer Ingelheim Investigational Site

Grandchamps, , France

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1235.7.3302D Boehringer Ingelheim Investigational Site

Guérigny, , France

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1235.7.3310A Boehringer Ingelheim Investigational Site

Jarny, , France

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1235.7.3301L Boehringer Ingelheim Investigational Site

La Chapelle /s Erdre, , France

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1235.7.3301J Boehringer Ingelheim Investigational Site

La Chapelle-sur-Erdre, , France

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1235.7.3304A Boehringer Ingelheim Investigational Site

La Fresnais, , France

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1235.7.3308E Boehringer Ingelheim Investigational Site

La Jubaudière, , France

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1235.7.3301G Boehringer Ingelheim Investigational Site

La Montagne, , France

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1235.7.3307D Boehringer Ingelheim Investigational Site

Le Mesnil-en-Vallée, , France

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1235.7.3301E Boehringer Ingelheim Investigational Site

Le Temple-de-Bretagne, , France

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1235.7.3309F Boehringer Ingelheim Investigational Site

Les Ponts-de-Cé, , France

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1235.7.3305B Boehringer Ingelheim Investigational Site

Louvigné Le Bais, , France

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1235.7.3307E Boehringer Ingelheim Investigational Site

Mouliherne, , France

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1235.7.3306A Boehringer Ingelheim Investigational Site

Mûrs-Erigné, , France

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1235.7.3307A Boehringer Ingelheim Investigational Site

Mûrs-Erigné, , France

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1235.7.3301A Boehringer Ingelheim Investigational Site

Nantes, , France

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1235.7.3301B Boehringer Ingelheim Investigational Site

Nantes, , France

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1235.7.3301D Boehringer Ingelheim Investigational Site

Nantes, , France

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1235.7.3301M Boehringer Ingelheim Investigational Site

Nantes, , France

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1235.7.3302A Boehringer Ingelheim Investigational Site

Nevers, , France

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1235.7.3302F Boehringer Ingelheim Investigational Site

Nevers, , France

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1235.7.3301I Boehringer Ingelheim Investigational Site

Nort-sur-Erdre, , France

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1235.7.3301C Boehringer Ingelheim Investigational Site

Orvault, , France

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1235.7.3307F Boehringer Ingelheim Investigational Site

Parçay-les-Pins, , France

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1235.7.3301F Boehringer Ingelheim Investigational Site

Saint Aubin Les Châteaux, , France

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1235.7.3306F Boehringer Ingelheim Investigational Site

Saint-Georges-de-Montaigu, , France

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1235.7.3304B Boehringer Ingelheim Investigational Site

Saint-Ouen-la-Rouërie, , France

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1235.7.3301N Boehringer Ingelheim Investigational Site

Sautron, , France

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1235.7.3306B Boehringer Ingelheim Investigational Site

Segré, , France

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1235.7.3306E Boehringer Ingelheim Investigational Site

Thouars, , France

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1235.7.3304C Boehringer Ingelheim Investigational Site

Tinténiac, , France

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1235.7.3308A Boehringer Ingelheim Investigational Site

Vihiers, , France

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1235.7.31008 Boehringer Ingelheim Investigational Site

Beerzerveld, , Netherlands

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1235.7.31006 Boehringer Ingelheim Investigational Site

Bennebroek, , Netherlands

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1235.7.31004 Boehringer Ingelheim Investigational Site

Hoogwoud, , Netherlands

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1235.7.31003 Boehringer Ingelheim Investigational Site

Musselkanaal, , Netherlands

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1235.7.31007 Boehringer Ingelheim Investigational Site

Nijverdal, , Netherlands

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1235.7.31001 Boehringer Ingelheim Investigational Site

Oude Pekela, , Netherlands

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1235.7.31005 Boehringer Ingelheim Investigational Site

Roelofarendsveen, , Netherlands

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1235.7.31010 Boehringer Ingelheim Investigational Site

Voerendaal, , Netherlands

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1235.7.47001 Boehringer Ingelheim Investigational Site

Ålesund, , Norway

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1235.7.47002 Boehringer Ingelheim Investigational Site

Bergen, , Norway

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1235.7.47003 Boehringer Ingelheim Investigational Site

Hamar, , Norway

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1235.7.47004 Boehringer Ingelheim Investigational Site

Oslo, , Norway

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1235.7.63006 Boehringer Ingelheim Investigational Site

Makati City, , Philippines

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1235.7.63001 Boehringer Ingelheim Investigational Site

Manila, , Philippines

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1235.7.63002 Boehringer Ingelheim Investigational Site

Manila, , Philippines

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1235.7.63009 Boehringer Ingelheim Investigational Site

Manila, , Philippines

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1235.7.63008 Boehringer Ingelheim Investigational Site

Pasay, , Philippines

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1235.7.63005 Boehringer Ingelheim Investigational Site

Pasig, , Philippines

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1235.7.63003 Boehringer Ingelheim Investigational Site

Quezon City, , Philippines

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1235.7.63007 Boehringer Ingelheim Investigational Site

Quezon City, , Philippines

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1235.7.27003 Boehringer Ingelheim Investigational Site

Boksburg, , South Africa

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1235.7.27006 Boehringer Ingelheim Investigational Site

Cape Town, , South Africa

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1235.7.27009 Boehringer Ingelheim Investigational Site

Cape Town, , South Africa

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1235.7.27010 Boehringer Ingelheim Investigational Site

Cape Town, , South Africa

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1235.7.27004 Boehringer Ingelheim Investigational Site

Durban, , South Africa

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1235.7.27007 Boehringer Ingelheim Investigational Site

Johannesburg, , South Africa

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1235.7.27008 Boehringer Ingelheim Investigational Site

Johannesburg, , South Africa

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1235.7.27001 Boehringer Ingelheim Investigational Site

Krugersdorp, , South Africa

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1235.7.27005 Boehringer Ingelheim Investigational Site

Lenasia, , South Africa

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1235.7.27002 Boehringer Ingelheim Investigational Site

Pretoria, , South Africa

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1235.7.82007 Boehringer Ingelheim Investigational Site

Busan, , South Korea

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1235.7.82001 Boehringer Ingelheim Investigational Site

Daegu, , South Korea

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1235.7.82006 Boehringer Ingelheim Investigational Site

Daejeon, , South Korea

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1235.7.82004 Boehringer Ingelheim Investigational Site

Gangwon-Do, , South Korea

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1235.7.82008 Boehringer Ingelheim Investigational Site

Gwangju, , South Korea

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1235.7.82002 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

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1235.7.82003 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

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1235.7.82005 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

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1235.7.46002 Boehringer Ingelheim Investigational Site

Gothenburg, , Sweden

Site Status

1235.7.46003 Boehringer Ingelheim Investigational Site

Gothenburg, , Sweden

Site Status

1235.7.46005 Boehringer Ingelheim Investigational Site

Luleå, , Sweden

Site Status

1235.7.46004 Boehringer Ingelheim Investigational Site

Rättvik, , Sweden

Site Status

1235.7.46001 Boehringer Ingelheim Investigational Site

Stockholm, , Sweden

Site Status

1235.7.88605 Boehringer Ingelheim Investigational Site

Changhua, , Taiwan

Site Status

1235.7.88608 Boehringer Ingelheim Investigational Site

Hualien City, , Taiwan

Site Status

1235.7.88601 Boehringer Ingelheim Investigational Site

Kaohsiung City, , Taiwan

Site Status

1235.7.88603 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

References

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Neldam S, Edwards C, Lang M, Jones R; TEAMSTA-5 and TEAMSTA-10 Investigators. Long-Term Tolerability and Efficacy of Single-Pill Combinations of Telmisartan 40-80 mg Plus Amlodipine 5 or 10 mg in Patients Whose Blood Pressure Was Not Initially Controlled by Amlodipine 5-10 mg: Open-Label, Long-Term Follow-Ups of the TEAMSTA-5 and TEAMSTA-10 Studies. Curr Ther Res Clin Exp. 2012 Feb;73(1-2):65-84. doi: 10.1016/j.curtheres.2012.02.004.

Reference Type DERIVED
PMID: 24653513 (View on PubMed)

Other Identifiers

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EUDRACT2007-002410-19

Identifier Type: -

Identifier Source: secondary_id

1235.7

Identifier Type: -

Identifier Source: org_study_id

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