Clinical trial NCT00614380: Open Label Study Telmisartan and Amlodipine in Hypertension
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2008-02-13
Enrollment: 976
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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 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

Primary outcomes:
measure: Trough Seated Diastolic Blood Pressure (DBP) Control
timeFrame: End of study (34 weeks or last value on treatment)
Secondary outcomes:
measure: Trough Seated Systolic Blood Pressure (SBP) Control
timeFrame: End of study (34 weeks or last value on treatment)
measure: Change From Baseline in Trough Seated Diastolic Blood Pressure
timeFrame: End of study (34 weeks or last value on treatment)
measure: Change in DBP From Last Available Trough in 1235.5 to Last Available Trough in 1235.7
timeFrame: End of study (34 weeks or last value on treatment)
measure: Change From Baseline in Trough Seated Systolic Blood Pressure
timeFrame: End of study (34 weeks or last value on treatment)
measure: Change in SBP From Last Available Trough in 1235.5 to Last Available Trough in 1235.7
timeFrame: End of study (34 weeks or last value on treatment)
measure: Trough Seated DBP Response
timeFrame: End of study (34 weeks or last value on treatment)
measure: Trough Seated SBP Response
timeFrame: End of study (34 weeks or last value on treatment)
measure: Trough Blood Pressure (BP) Normality Classes
timeFrame: End of study (34 weeks or last value on treatment)
measure: Time to First Additional Antihypertensive
timeFrame: At any point during open-label treatment
measure: Patients Requiring Additional Antihypertensive Therapy to Achieve DBP Control
timeFrame: At any point during open-label treatment
measure: Additional Reduction in DBP by Use of Additional Antihypertensive Therapy
timeFrame: At any point during open-label treatment
measure: Additional Reduction in SBP by Use of Additional Antihypertensive Therapy
timeFrame: At any point during open-label treatment
measure: Trough DBP Control Pre- and Post- Uptitration
timeFrame: At any point during open-label treatment
Other outcomes:
Locations:
city: Aywaille
country: Belgium
facility: 1235.7.32004 Boehringer Ingelheim Investigational Site
city: Gozée
country: Belgium
facility: 1235.7.32010 Boehringer Ingelheim Investigational Site
city: Linkebeek
country: Belgium
facility: 1235.7.32008 Boehringer Ingelheim Investigational Site
city: Mol
country: Belgium
facility: 1235.7.32003 Boehringer Ingelheim Investigational Site
city: Natoye
country: Belgium
facility: 1235.7.32007 Boehringer Ingelheim Investigational Site
city: Tienen
country: Belgium
facility: 1235.7.32002 Boehringer Ingelheim Investigational Site
city: Turnhout
country: Belgium
facility: 1235.7.32005 Boehringer Ingelheim Investigational Site
city: Coquitlam
country: Canada
facility: 1235.7.20001 Boehringer Ingelheim Investigational Site
state: British Columbia
city: Vancouver
country: Canada
facility: 1235.7.20011 Boehringer Ingelheim Investigational Site
state: British Columbia
city: Bay Roberts
country: Canada
facility: 1235.7.20007 Boehringer Ingelheim Investigational Site
state: Newfoundland and Labrador
city: Mount Pearl
country: Canada
facility: 1235.7.20005 Boehringer Ingelheim Investigational Site
state: Newfoundland and Labrador
city: St. John's
country: Canada
facility: 1235.7.20008 Boehringer Ingelheim Investigational Site
state: Newfoundland and Labrador
city: Corunna
country: Canada
facility: 1235.7.20013 Boehringer Ingelheim Investigational Site
state: Ontario
city: Etobicoke
country: Canada
facility: 1235.7.20014 Boehringer Ingelheim Investigational Site
state: Ontario
city: Hamilton
country: Canada
facility: 1235.7.20010 Boehringer Ingelheim Investigational Site
state: Ontario
city: London
country: Canada
facility: 1235.7.20012 Boehringer Ingelheim Investigational Site
state: Ontario
city: Ottawa
country: Canada
facility: 1235.7.20009 Boehringer Ingelheim Investigational Site
state: Ontario
city: Sarnia
country: Canada
facility: 1235.7.20006 Boehringer Ingelheim Investigational Site
state: Ontario
city: Sainte-Foy
country: Canada
facility: 1235.7.20003 Boehringer Ingelheim Investigational Site
state: Quebec
city: Birkerød
country: Denmark
facility: 1235.7.45002 Boehringer Ingelheim Investigational Site
city: Haderslev
country: Denmark
facility: 1235.7.45005 Boehringer Ingelheim Investigational Site
city: Herning
country: Denmark
facility: 1235.7.45008 Boehringer Ingelheim Investigational Site
city: Hinnerup
country: Denmark
facility: 1235.7.45009 Boehringer Ingelheim Investigational Site
city: Rødovre
country: Denmark
facility: 1235.7.45001 Boehringer Ingelheim Investigational Site
city: Rødovre
country: Denmark
facility: 1235.7.45006 Boehringer Ingelheim Investigational Site
city: Vaerløse
country: Denmark
facility: 1235.7.45003 Boehringer Ingelheim Investigational Site
city: Vildbjerg
country: Denmark
facility: 1235.7.45007 Boehringer Ingelheim Investigational Site
city: Joensuu
country: Finland
facility: 1235.7.35003 Boehringer Ingelheim Investigational Site
city: Joensuu
country: Finland
facility: 1235.7.35004 Boehringer Ingelheim Investigational Site
city: Turku
country: Finland
facility: 1235.7.35001 Boehringer Ingelheim Investigational Site
city: Turku
country: Finland
facility: 1235.7.35002 Boehringer Ingelheim Investigational Site
city: Aigrefeuille S/Maine
country: France
facility: 1235.7.3301H Boehringer Ingelheim Investigational Site
city: Angers
country: France
facility: 1235.7.3306C Boehringer Ingelheim Investigational Site
city: Angers
country: France
facility: 1235.7.3309B Boehringer Ingelheim Investigational Site
city: Angers
country: France
facility: 1235.7.3309C Boehringer Ingelheim Investigational Site
city: Angers
country: France
facility: 1235.7.3309E Boehringer Ingelheim Investigational Site
city: Avrille
country: France
facility: 1235.7.3309D Boehringer Ingelheim Investigational Site
city: Beaucouze
country: France
facility: 1235.7.3309A Boehringer Ingelheim Investigational Site
city: Bourg des cptes
country: France
facility: 1235.7.3305A Boehringer Ingelheim Investigational Site
city: Briollay
country: France
facility: 1235.7.3306D Boehringer Ingelheim Investigational Site
city: Cholet
country: France
facility: 1235.7.3308B Boehringer Ingelheim Investigational Site
city: Cholet
country: France
facility: 1235.7.3308F Boehringer Ingelheim Investigational Site
city: Garchizy
country: France
facility: 1235.7.3302C Boehringer Ingelheim Investigational Site
city: Grandchamps
country: France
facility: 1235.7.3303C Boehringer Ingelheim Investigational Site
city: Guerigny
country: France
facility: 1235.7.3302D Boehringer Ingelheim Investigational Site
city: Jarny
country: France
facility: 1235.7.3310A Boehringer Ingelheim Investigational Site
city: La Chapelle /s Erdre
country: France
facility: 1235.7.3301L Boehringer Ingelheim Investigational Site
city: La Chapelle sur Erdre
country: France
facility: 1235.7.3301J Boehringer Ingelheim Investigational Site
city: La Fresnais
country: France
facility: 1235.7.3304A Boehringer Ingelheim Investigational Site
city: La Jubaudière
country: France
facility: 1235.7.3308E Boehringer Ingelheim Investigational Site
city: La Montagne
country: France
facility: 1235.7.3301G Boehringer Ingelheim Investigational Site
city: Le Mesnil en Vallée
country: France
facility: 1235.7.3307D Boehringer Ingelheim Investigational Site
city: Le Temple de Bretagne
country: France
facility: 1235.7.3301E Boehringer Ingelheim Investigational Site
city: Les Ponts de CE
country: France
facility: 1235.7.3309F Boehringer Ingelheim Investigational Site
city: Louvigné le Bais
country: France
facility: 1235.7.3305B Boehringer Ingelheim Investigational Site
city: Mouliherne
country: France
facility: 1235.7.3307E Boehringer Ingelheim Investigational Site
city: Murs Erigne
country: France
facility: 1235.7.3306A Boehringer Ingelheim Investigational Site
city: Murs-Erigne
country: France
facility: 1235.7.3307A Boehringer Ingelheim Investigational Site
city: Nantes
country: France
facility: 1235.7.3301A Boehringer Ingelheim Investigational Site
city: Nantes
country: France
facility: 1235.7.3301B Boehringer Ingelheim Investigational Site
city: Nantes
country: France
facility: 1235.7.3301D Boehringer Ingelheim Investigational Site
city: Nantes
country: France
facility: 1235.7.3301M Boehringer Ingelheim Investigational Site
city: Nevers
country: France
facility: 1235.7.3302A Boehringer Ingelheim Investigational Site
city: Nevers
country: France
facility: 1235.7.3302F Boehringer Ingelheim Investigational Site
city: Nort sur Erdre
country: France
facility: 1235.7.3301I Boehringer Ingelheim Investigational Site
city: Orvault
country: France
facility: 1235.7.3301C Boehringer Ingelheim Investigational Site
city: Parcay les Pins
country: France
facility: 1235.7.3307F Boehringer Ingelheim Investigational Site
city: Sautron
country: France
facility: 1235.7.3301N Boehringer Ingelheim Investigational Site
city: Segre
country: France
facility: 1235.7.3306B Boehringer Ingelheim Investigational Site
city: St Aubin les Châteaux
country: France
facility: 1235.7.3301F Boehringer Ingelheim Investigational Site
city: St Georges de Montaigu
country: France
facility: 1235.7.3306F Boehringer Ingelheim Investigational Site
city: St Ouen La Rouerie
country: France
facility: 1235.7.3304B Boehringer Ingelheim Investigational Site
city: Thouars
country: France
facility: 1235.7.3306E Boehringer Ingelheim Investigational Site
city: Tinténiac
country: France
facility: 1235.7.3304C Boehringer Ingelheim Investigational Site
city: Vihiers
country: France
facility: 1235.7.3308A Boehringer Ingelheim Investigational Site
city: Busan
country: Korea, Republic of
facility: 1235.7.82007 Boehringer Ingelheim Investigational Site
city: Daegu
country: Korea, Republic of
facility: 1235.7.82001 Boehringer Ingelheim Investigational Site
city: Daejon
country: Korea, Republic of
facility: 1235.7.82006 Boehringer Ingelheim Investigational Site
city: Gangwon-Do
country: Korea, Republic of
facility: 1235.7.82004 Boehringer Ingelheim Investigational Site
city: Gwangju
country: Korea, Republic of
facility: 1235.7.82008 Boehringer Ingelheim Investigational Site
city: Seoul
country: Korea, Republic of
facility: 1235.7.82002 Boehringer Ingelheim Investigational Site
city: Seoul
country: Korea, Republic of
facility: 1235.7.82003 Boehringer Ingelheim Investigational Site
city: Seoul
country: Korea, Republic of
facility: 1235.7.82005 Boehringer Ingelheim Investigational Site
city: Beerzerveld
country: Netherlands
facility: 1235.7.31008 Boehringer Ingelheim Investigational Site
city: Bennebroek
country: Netherlands
facility: 1235.7.31006 Boehringer Ingelheim Investigational Site
city: Hoogwoud
country: Netherlands
facility: 1235.7.31004 Boehringer Ingelheim Investigational Site
city: Musselkanaal
country: Netherlands
facility: 1235.7.31003 Boehringer Ingelheim Investigational Site
city: Nijverdal
country: Netherlands
facility: 1235.7.31007 Boehringer Ingelheim Investigational Site
city: Oude Pekela
country: Netherlands
facility: 1235.7.31001 Boehringer Ingelheim Investigational Site
city: Roelofarendsveen
country: Netherlands
facility: 1235.7.31005 Boehringer Ingelheim Investigational Site
city: Voerendaal
country: Netherlands
facility: 1235.7.31010 Boehringer Ingelheim Investigational Site
city: Bergen
country: Norway
facility: 1235.7.47002 Boehringer Ingelheim Investigational Site
city: Hamar
country: Norway
facility: 1235.7.47003 Boehringer Ingelheim Investigational Site
city: Oslo
country: Norway
facility: 1235.7.47004 Boehringer Ingelheim Investigational Site
city: Ålesund
country: Norway
facility: 1235.7.47001 Boehringer Ingelheim Investigational Site
city: Makati City
country: Philippines
facility: 1235.7.63006 Boehringer Ingelheim Investigational Site
city: Manila
country: Philippines
facility: 1235.7.63001 Boehringer Ingelheim Investigational Site
city: Manila
country: Philippines
facility: 1235.7.63002 Boehringer Ingelheim Investigational Site
city: Manila
country: Philippines
facility: 1235.7.63009 Boehringer Ingelheim Investigational Site
city: Pasay City
country: Philippines
facility: 1235.7.63008 Boehringer Ingelheim Investigational Site
city: Pasig City
country: Philippines
facility: 1235.7.63005 Boehringer Ingelheim Investigational Site
city: Quezon City
country: Philippines
facility: 1235.7.63003 Boehringer Ingelheim Investigational Site
city: Quezon City
country: Philippines
facility: 1235.7.63007 Boehringer Ingelheim Investigational Site
city: Boksburg
country: South Africa
facility: 1235.7.27003 Boehringer Ingelheim Investigational Site
city: Cape Town
country: South Africa
facility: 1235.7.27006 Boehringer Ingelheim Investigational Site
city: Cape Town
country: South Africa
facility: 1235.7.27009 Boehringer Ingelheim Investigational Site
city: Cape Town
country: South Africa
facility: 1235.7.27010 Boehringer Ingelheim Investigational Site
city: Durban
country: South Africa
facility: 1235.7.27004 Boehringer Ingelheim Investigational Site
city: Johannesburg
country: South Africa
facility: 1235.7.27007 Boehringer Ingelheim Investigational Site
city: Johannesburg
country: South Africa
facility: 1235.7.27008 Boehringer Ingelheim Investigational Site
city: Krugersdorp
country: South Africa
facility: 1235.7.27001 Boehringer Ingelheim Investigational Site
city: Lenasia
country: South Africa
facility: 1235.7.27005 Boehringer Ingelheim Investigational Site
city: Pretoria
country: South Africa
facility: 1235.7.27002 Boehringer Ingelheim Investigational Site
city: Göteborg
country: Sweden
facility: 1235.7.46002 Boehringer Ingelheim Investigational Site
city: Göteborg
country: Sweden
facility: 1235.7.46003 Boehringer Ingelheim Investigational Site
city: Luleå
country: Sweden
facility: 1235.7.46005 Boehringer Ingelheim Investigational Site
city: Rättvik
country: Sweden
facility: 1235.7.46004 Boehringer Ingelheim Investigational Site
city: Stockholm
country: Sweden
facility: 1235.7.46001 Boehringer Ingelheim Investigational Site
city: Changhua
country: Taiwan
facility: 1235.7.88605 Boehringer Ingelheim Investigational Site
city: Hualien City
country: Taiwan
facility: 1235.7.88608 Boehringer Ingelheim Investigational Site
city: Kaohsiung
country: Taiwan
facility: 1235.7.88601 Boehringer Ingelheim Investigational Site
city: Taichung
country: Taiwan
facility: 1235.7.88603 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: 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.