Open Label Study Telmisartan and Amlodipine in Hypertension

Condition(s) targeted: Hypertension

Intervention: telmisartan/amlodipine 40/5 mg fixed combination (Drug); telmisartan/amlodipine 80/5 mg fixed combination (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Boehringer Ingelheim Pharmaceuticals

Official(s) and/or principal investigator(s):
Boehringer Ingelheim, Study Chair, Affiliation: Boehringer Ingelheim Pharmaceuticals

Overall contact:
Boehringer Ingelheim Study Coordinator, Phone: 800-542-6257, Ext: Option 4, Email: clintriage.rdg@boehringer-ingelheim.com

The primary objective of this trial is to assess the efficacy and safety of the fixed dose combinations T40/A5 or T80/A5 during long-term open-label treatment.

Official title: An Open Label Follow-up Trial of the Efficacy and Safety of Chronic Administration of the Combination of Telmisartan 40mg + Amlodipine 5mg or the Combination of Telmisartan 80mg + Amlodipine 5mg Tablets Alone or in Combination With Other Antihypertensive Medications in Patients With Hypertension.

Study design: Treatment, Safety/Efficacy Study

Primary outcome: The primary endpoint is the proportion of patients achieving DBP control

Secondary outcome: change from baseline in seated through DBP change frmo baseline in seated SBP proportion of patients achieving DBP response proportion of patients achieving SBP response

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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 A5 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 T40/A5 or T80/A5

3. discontinuation from the preceding trial because of any adverse event or any other reason

4. known or suspected secondary hypertension

5. mean seated SBP => 180 mmHg and/or mean seated DBP => 120 mmHg at any visit

Boehringer Ingelheim Study Coordinator, Phone: 800-542-6257, Ext: Option 4, Email: clintriage.rdg@boehringer-ingelheim.com

1235.7.32002 Boehringer Ingelheim Investigational Site, Tienen, Belgium; Active, not recruiting

1235.7.32003 Boehringer Ingelheim Investigational Site, Mol, Belgium; Active, not recruiting

1235.7.32004 Boehringer Ingelheim Investigational Site, Aywaille, Belgium; Active, not recruiting

1235.7.32005 Boehringer Ingelheim Investigational Site, Turnhout, Belgium; Active, not recruiting

1235.7.32007 Boehringer Ingelheim Investigational Site, Natoye, Belgium; Active, not recruiting

1235.7.32008 Boehringer Ingelheim Investigational Site, Linkebeek, Belgium; Active, not recruiting

1235.7.32010 Boehringer Ingelheim Investigational Site, Gozée, Belgium; Active, not recruiting

1235.7.45001 Boehringer Ingelheim Investigational Site, Rødovre, Denmark; Recruiting

1235.7.45002 Boehringer Ingelheim Investigational Site, Birkerød, Denmark; Recruiting

1235.7.45003 Boehringer Ingelheim Investigational Site, Vaerløse, Denmark; Recruiting

1235.7.45005 Boehringer Ingelheim Investigational Site, Haderslev, Denmark; Recruiting

1235.7.45006 Boehringer Ingelheim Investigational Site, Rødovre, Denmark; Recruiting

1235.7.45007 Boehringer Ingelheim Investigational Site, Vildbjerg, Denmark; Recruiting

1235.7.45008 Boehringer Ingelheim Investigational Site, Herning, Denmark; Recruiting

1235.7.45009 Boehringer Ingelheim Investigational Site, Hinnerup, Denmark; Recruiting

1235.7.35001 Boehringer Ingelheim Investigational Site, TURKU, Finland; Active, not recruiting

1235.7.35002 Boehringer Ingelheim Investigational Site, Turku, Finland; Active, not recruiting

1235.7.35003 Boehringer Ingelheim Investigational Site, Joensuu, Finland; Active, not recruiting

1235.7.35004 Boehringer Ingelheim Investigational Site, Joensuu, Finland; Active, not recruiting

1235.7.3301E Boehringer Ingelheim Investigational Site, Le Temple de Bretagne, France; Recruiting

1235.7.3301F Boehringer Ingelheim Investigational Site, St Aubin les Châteaux, France; Recruiting

1235.7.3301A Boehringer Ingelheim Investigational Site, Nantes, France; Recruiting

1235.7.3301G Boehringer Ingelheim Investigational Site, La Montagne, France; Recruiting

1235.7.3301B Boehringer Ingelheim Investigational Site, Nantes, France; Recruiting

1235.7.3301C Boehringer Ingelheim Investigational Site, ORVAULT, France; Recruiting

1235.7.3301H Boehringer Ingelheim Investigational Site, Aigrefeuille S/Maine, France; Recruiting

1235.7.3301D Boehringer Ingelheim Investigational Site, Nantes, France; Recruiting

1235.7.3301N Boehringer Ingelheim Investigational Site, Sautron, France; Recruiting

1235.7.3301I Boehringer Ingelheim Investigational Site, Nort sur Erdre, France; Recruiting

1235.7.3301J Boehringer Ingelheim Investigational Site, La Chapelle sur Erdre, France; Recruiting

1235.7.3301L Boehringer Ingelheim Investigational Site, La Chapelle /s Erdre, France; Recruiting

1235.7.3301M Boehringer Ingelheim Investigational Site, Nantes, France; Recruiting

1235.7.3302A Boehringer Ingelheim Investigational Site, Nevers, France; Recruiting

1235.7.3302C Boehringer Ingelheim Investigational Site, Garchizy, France; Recruiting

1235.7.3302D Boehringer Ingelheim Investigational Site, Guerigny, France; Recruiting

1235.7.3303C Boehringer Ingelheim Investigational Site, Grandchamps, France; Recruiting

1235.7.3304B Boehringer Ingelheim Investigational Site, St Ouen La Rouerie, France; Recruiting

1235.7.3304C Boehringer Ingelheim Investigational Site, Tinténiac, France; Recruiting

1235.7.3305B Boehringer Ingelheim Investigational Site, Louvigné le Bais, France; Recruiting

1235.7.3306A Boehringer Ingelheim Investigational Site, Murs Erigne, France; Recruiting

1235.7.3306C Boehringer Ingelheim Investigational Site, Angers, France; Recruiting

1235.7.3306F Boehringer Ingelheim Investigational Site, St Georges de Montaigu, France; Recruiting

1235.7.3306B Boehringer Ingelheim Investigational Site, Segre, France; Recruiting

1235.7.3306D Boehringer Ingelheim Investigational Site, Briollay, France; Recruiting

1235.7.3307A Boehringer Ingelheim Investigational Site, Murs-Erigne, France; Recruiting

1235.7.3307F Boehringer Ingelheim Investigational Site, Parcay les Pins, France; Recruiting

1235.7.3307D Boehringer Ingelheim Investigational Site, Le Mesnil en Vallée, France; Recruiting

1235.7.3308A Boehringer Ingelheim Investigational Site, Vihiers, France; Recruiting

1235.7.3308D Boehringer Ingelheim Investigational Site, Cholet, France; Recruiting

1235.7.3308E Boehringer Ingelheim Investigational Site, La Jubaudière, France; Recruiting

1235.7.3308F Boehringer Ingelheim Investigational Site, Cholet, France; Recruiting

1235.7.3309A Boehringer Ingelheim Investigational Site, Beaucouze, France; Recruiting

1235.7.3309F Boehringer Ingelheim Investigational Site, Les Ponts de CE, France; Recruiting

1235.7.3309B Boehringer Ingelheim Investigational Site, Angers, France; Recruiting

1235.7.3309C Boehringer Ingelheim Investigational Site, Angers, France; Recruiting

1235.7.3309D Boehringer Ingelheim Investigational Site, Avrille, France; Recruiting

1235.7.3309E Boehringer Ingelheim Investigational Site, Angers, France; Recruiting

1235.7.3310A Boehringer Ingelheim Investigational Site, Jarny, France; Recruiting

1235.7.3304A Boehringer Ingelheim Investigational Site, La Fresnais, France; Recruiting

1235.7.3305A Boehringer Ingelheim Investigational Site, Bourg des cptes, France; Recruiting

1235.7.3306E Boehringer Ingelheim Investigational Site, Thouars, France; Recruiting

1235.7.3308B Boehringer Ingelheim Investigational Site, Le Mesnil en Vallée, France; Recruiting

1235.7.3302F Boehringer Ingelheim Investigational Site, Nevers, France; Recruiting

1235.7.82001 Boehringer Ingelheim Investigational Site, Daegu, Korea, Republic of; Active, not recruiting

1235.7.82002 Boehringer Ingelheim Investigational Site, Seoul, Korea, Republic of; Active, not recruiting

1235.7.82003 Boehringer Ingelheim Investigational Site, Seoul, Korea, Republic of; Active, not recruiting

1235.7.82004 Boehringer Ingelheim Investigational Site, Gangwon-Do, Korea, Republic of; Recruiting

1235.7.82005 Boehringer Ingelheim Investigational Site, Seoul, Korea, Republic of; Active, not recruiting

1235.7.82006 Boehringer Ingelheim Investigational Site, Daejon, Korea, Republic of; Active, not recruiting

1235.7.82007 Boehringer Ingelheim Investigational Site, Busan, Korea, Republic of; Active, not recruiting

1235.7.82008 Boehringer Ingelheim Investigational Site, Gwangju, Korea, Republic of; Active, not recruiting

1235.7.31001 Boehringer Ingelheim Investigational Site, Oude Pekela, Netherlands; Recruiting

1235.7.31003 Boehringer Ingelheim Investigational Site, Musselkanaal, Netherlands; Recruiting

1235.7.31004 Boehringer Ingelheim Investigational Site, Hoogwoud, Netherlands; Recruiting

1235.7.31005 Boehringer Ingelheim Investigational Site, Roelofarendsveen, Netherlands; Recruiting

1235.7.31006 Boehringer Ingelheim Investigational Site, Bennebroek, Netherlands; Recruiting

1235.7.31007 Boehringer Ingelheim Investigational Site, Nijverdal, Netherlands; Recruiting

1235.7.31008 Boehringer Ingelheim Investigational Site, Beerzerveld, Netherlands; Recruiting

1235.7.31010 Boehringer Ingelheim Investigational Site, Voerendaal, Netherlands; Recruiting

1235.7.47001 Boehringer Ingelheim Investigational Site, ÅLESUND, Norway; Not yet recruiting

1235.7.47002 Boehringer Ingelheim Investigational Site, BERGEN, Norway; Not yet recruiting

1235.7.47003 Boehringer Ingelheim Investigational Site, Hamar, Norway; Not yet recruiting

1235.7.47004 Boehringer Ingelheim Investigational Site, OSLO, Norway; Not yet recruiting

1235.7.63001 Boehringer Ingelheim Investigational Site, Manila, Philippines; Recruiting

1235.7.63002 Boehringer Ingelheim Investigational Site, Manila, Philippines; Recruiting

1235.7.63003 Boehringer Ingelheim Investigational Site, Quezon City, Philippines; Recruiting

1235.7.63005 Boehringer Ingelheim Investigational Site, Pasig City, Philippines; Recruiting

1235.7.63006 Boehringer Ingelheim Investigational Site, Makati City, Philippines; Recruiting

1235.7.63007 Boehringer Ingelheim Investigational Site, Quezon City, Philippines; Recruiting

1235.7.63008 Boehringer Ingelheim Investigational Site, Pasay City, Philippines; Recruiting

1235.7.63009 Boehringer Ingelheim Investigational Site, Manila, Philippines; Recruiting

1235.7.27001 Boehringer Ingelheim Investigational Site, Krugersdorp, South Africa; Recruiting

1235.7.27002 Boehringer Ingelheim Investigational Site, Pretoria, South Africa; Recruiting

1235.7.27003 Boehringer Ingelheim Investigational Site, Boksburg, South Africa; Recruiting

1235.7.27004 Boehringer Ingelheim Investigational Site, Durban, South Africa; Recruiting

1235.7.27005 Boehringer Ingelheim Investigational Site, Lenasia, South Africa; Recruiting

1235.7.27006 Boehringer Ingelheim Investigational Site, Cape Town, South Africa; Recruiting

1235.7.27007 Boehringer Ingelheim Investigational Site, Johannesburg, South Africa; Not yet recruiting

1235.7.27008 Boehringer Ingelheim Investigational Site, Johannesburg, South Africa; Recruiting

1235.7.27009 Boehringer Ingelheim Investigational Site, Cape Town, South Africa; Not yet recruiting

1235.7.27010 Boehringer Ingelheim Investigational Site, Cape Town, South Africa; Recruiting

1235.7.46001 Boehringer Ingelheim Investigational Site, Stockholm, Sweden; Recruiting

1235.7.46002 Boehringer Ingelheim Investigational Site, Göteborg, Sweden; Recruiting

1235.7.46003 Boehringer Ingelheim Investigational Site, Göteborg, Sweden; Recruiting

1235.7.46004 Boehringer Ingelheim Investigational Site, Rättvik, Sweden; Recruiting

1235.7.46005 Boehringer Ingelheim Investigational Site, Luleå, Sweden; Recruiting

1235.7.88601 Boehringer Ingelheim Investigational Site, Kaohsiung, Taiwan; Active, not recruiting

1235.7.88605 Boehringer Ingelheim Investigational Site, Changhua, Taiwan; Active, not recruiting

1235.7.88603 Boehringer Ingelheim Investigational Site, Taichung, Taiwan; Active, not recruiting

1235.7.88608 Boehringer Ingelheim Investigational Site, Hualien City, Taiwan; Active, not recruiting

1235.7.20001 Boehringer Ingelheim Investigational Site, Coquitlam, British Columbia, Canada; Recruiting

1235.7.20011 Boehringer Ingelheim Investigational Site, Vancouver, British Columbia, Canada; Recruiting

1235.7.20005 Boehringer Ingelheim Investigational Site, Mount Pearl, Newfoundland and Labrador, Canada; Recruiting

1235.7.20007 Boehringer Ingelheim Investigational Site, Bay Roberts, Newfoundland and Labrador, Canada; Recruiting

1235.7.20008 Boehringer Ingelheim Investigational Site, St. John's, Newfoundland and Labrador, Canada; Recruiting

1235.7.20006 Boehringer Ingelheim Investigational Site, Sarnia, Ontario, Canada; Recruiting

1235.7.20009 Boehringer Ingelheim Investigational Site, Ottawa, Ontario, Canada; Recruiting

1235.7.20010 Boehringer Ingelheim Investigational Site, Hamilton, Ontario, Canada; Recruiting

1235.7.20012 Boehringer Ingelheim Investigational Site, London, Ontario, Canada; Recruiting

1235.7.20013 Boehringer Ingelheim Investigational Site, Corunna, Ontario, Canada; Recruiting

1235.7.20014 Boehringer Ingelheim Investigational Site, Etobicoke, Ontario, Canada; Recruiting

1235.7.20003 Boehringer Ingelheim Investigational Site, Sainte-Foy, Quebec, Canada; Recruiting

Starting date: January 2008
Last updated: December 17, 2008