HypertensionPhase 3NCT00614380

Open Label Study Telmisartan and Amlodipine in Hypertension

A Phase 3 study testing telmisartan/amlodipine 40/5 mg fixed combination and telmisartan/amlodipine 80/5 mg fixed combination in people with Hypertension, run by Boehringer Ingelheim at 122 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hypertension
What is being tested?: telmisartan/amlodipine 40/5 mg fixed combination and telmisartan/amlodipine 80/5 mg fixed combination
How many people: 976 participants
Where: 122 sitesin 12 countries
Study dates: Jan 2008to Mar 2009
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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
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
discontinuation from the preceding trial because of any adverse event or any other reason
known or suspected secondary hypertension
mean seated Systolic Blood Pressure => 180 mmHg and/or mean seated Diastolic Blood Pressure => 120 mmHg at any visit

Trial locations and contacts

122 sites in 12 countries.

Country

City, postcode or hospital

122 sites in 12 countries

France44 sites

1235.7.3301H Boehringer Ingelheim Investigational Site
Aigrefeuille S/Maine
1235.7.3306C Boehringer Ingelheim Investigational Site
Angers
1235.7.3309B Boehringer Ingelheim Investigational Site
Angers
1235.7.3309C Boehringer Ingelheim Investigational Site
Angers
1235.7.3309E Boehringer Ingelheim Investigational Site
Angers
1235.7.3309D Boehringer Ingelheim Investigational Site
Avrillé
1235.7.3309A Boehringer Ingelheim Investigational Site
Beaucouzé
1235.7.3305A Boehringer Ingelheim Investigational Site
Bourg Des Cptes
1235.7.3306D Boehringer Ingelheim Investigational Site
Briollay
1235.7.3308B Boehringer Ingelheim Investigational Site
Cholet
1235.7.3308F Boehringer Ingelheim Investigational Site
Cholet
1235.7.3302C Boehringer Ingelheim Investigational Site
Garchizy
1235.7.3303C Boehringer Ingelheim Investigational Site
Grandchamps
1235.7.3302D Boehringer Ingelheim Investigational Site
Guérigny
1235.7.3310A Boehringer Ingelheim Investigational Site
Jarny
1235.7.3301L Boehringer Ingelheim Investigational Site
La Chapelle /s Erdre
1235.7.3301J Boehringer Ingelheim Investigational Site
La Chapelle-sur-Erdre
1235.7.3304A Boehringer Ingelheim Investigational Site
La Fresnais
1235.7.3308E Boehringer Ingelheim Investigational Site
La Jubaudière
1235.7.3301G Boehringer Ingelheim Investigational Site
La Montagne
1235.7.3307D Boehringer Ingelheim Investigational Site
Le Mesnil-en-Vallée
1235.7.3301E Boehringer Ingelheim Investigational Site
Le Temple-de-Bretagne
1235.7.3309F Boehringer Ingelheim Investigational Site
Les Ponts-de-Cé
1235.7.3305B Boehringer Ingelheim Investigational Site
Louvigné Le Bais
1235.7.3307E Boehringer Ingelheim Investigational Site
Mouliherne
1235.7.3306A Boehringer Ingelheim Investigational Site
Mûrs-Erigné
1235.7.3307A Boehringer Ingelheim Investigational Site
Mûrs-Erigné
1235.7.3301A Boehringer Ingelheim Investigational Site
Nantes
1235.7.3301B Boehringer Ingelheim Investigational Site
Nantes
1235.7.3301D Boehringer Ingelheim Investigational Site
Nantes
1235.7.3301M Boehringer Ingelheim Investigational Site
Nantes
1235.7.3302A Boehringer Ingelheim Investigational Site
Nevers
1235.7.3302F Boehringer Ingelheim Investigational Site
Nevers
1235.7.3301I Boehringer Ingelheim Investigational Site
Nort-sur-Erdre
1235.7.3301C Boehringer Ingelheim Investigational Site
Orvault
1235.7.3307F Boehringer Ingelheim Investigational Site
Parçay-les-Pins
1235.7.3301F Boehringer Ingelheim Investigational Site
Saint Aubin Les Châteaux
1235.7.3306F Boehringer Ingelheim Investigational Site
Saint-Georges-de-Montaigu
1235.7.3304B Boehringer Ingelheim Investigational Site
Saint-Ouen-la-Rouërie
1235.7.3301N Boehringer Ingelheim Investigational Site
Sautron
1235.7.3306B Boehringer Ingelheim Investigational Site
Segré
1235.7.3306E Boehringer Ingelheim Investigational Site
Thouars
1235.7.3304C Boehringer Ingelheim Investigational Site
Tinténiac
1235.7.3308A Boehringer Ingelheim Investigational Site
Vihiers

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Canada12 sites

1235.7.20007 Boehringer Ingelheim Investigational Site
Bay Roberts, Newfoundland and Labrador
1235.7.20001 Boehringer Ingelheim Investigational Site
Coquitlam, British Columbia
1235.7.20013 Boehringer Ingelheim Investigational Site
Corunna, Ontario
1235.7.20014 Boehringer Ingelheim Investigational Site
Etobicoke, Ontario
1235.7.20010 Boehringer Ingelheim Investigational Site
Hamilton, Ontario
1235.7.20012 Boehringer Ingelheim Investigational Site
London, Ontario
1235.7.20005 Boehringer Ingelheim Investigational Site
Mount Pearl, Newfoundland and Labrador
1235.7.20009 Boehringer Ingelheim Investigational Site
Ottawa, Ontario
1235.7.20003 Boehringer Ingelheim Investigational Site
Sainte-Foy, Quebec
1235.7.20006 Boehringer Ingelheim Investigational Site
Sarnia, Ontario
1235.7.20008 Boehringer Ingelheim Investigational Site
St. John's, Newfoundland and Labrador
1235.7.20011 Boehringer Ingelheim Investigational Site
Vancouver, British Columbia

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South Africa10 sites

1235.7.27003 Boehringer Ingelheim Investigational Site
Boksburg
1235.7.27006 Boehringer Ingelheim Investigational Site
Cape Town
1235.7.27009 Boehringer Ingelheim Investigational Site
Cape Town
1235.7.27010 Boehringer Ingelheim Investigational Site
Cape Town
1235.7.27004 Boehringer Ingelheim Investigational Site
Durban
1235.7.27007 Boehringer Ingelheim Investigational Site
Johannesburg
1235.7.27008 Boehringer Ingelheim Investigational Site
Johannesburg
1235.7.27001 Boehringer Ingelheim Investigational Site
Krugersdorp
1235.7.27005 Boehringer Ingelheim Investigational Site
Lenasia
1235.7.27002 Boehringer Ingelheim Investigational Site
Pretoria

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Denmark8 sites

1235.7.45002 Boehringer Ingelheim Investigational Site
Birkerød
1235.7.45005 Boehringer Ingelheim Investigational Site
Haderslev
1235.7.45008 Boehringer Ingelheim Investigational Site
Herning
1235.7.45009 Boehringer Ingelheim Investigational Site
Hinnerup
1235.7.45001 Boehringer Ingelheim Investigational Site
Rødovre Municipality
1235.7.45006 Boehringer Ingelheim Investigational Site
Rødovre Municipality
1235.7.45003 Boehringer Ingelheim Investigational Site
Vaerløse
1235.7.45007 Boehringer Ingelheim Investigational Site
Vildbjerg

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Netherlands8 sites

1235.7.31008 Boehringer Ingelheim Investigational Site
Beerzerveld
1235.7.31006 Boehringer Ingelheim Investigational Site
Bennebroek
1235.7.31004 Boehringer Ingelheim Investigational Site
Hoogwoud
1235.7.31003 Boehringer Ingelheim Investigational Site
Musselkanaal
1235.7.31007 Boehringer Ingelheim Investigational Site
Nijverdal
1235.7.31001 Boehringer Ingelheim Investigational Site
Oude Pekela
1235.7.31005 Boehringer Ingelheim Investigational Site
Roelofarendsveen
1235.7.31010 Boehringer Ingelheim Investigational Site
Voerendaal

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Philippines8 sites

1235.7.63006 Boehringer Ingelheim Investigational Site
Makati City
1235.7.63001 Boehringer Ingelheim Investigational Site
Manila
1235.7.63002 Boehringer Ingelheim Investigational Site
Manila
1235.7.63009 Boehringer Ingelheim Investigational Site
Manila
1235.7.63008 Boehringer Ingelheim Investigational Site
Pasay
1235.7.63005 Boehringer Ingelheim Investigational Site
Pasig
1235.7.63003 Boehringer Ingelheim Investigational Site
Quezon City
1235.7.63007 Boehringer Ingelheim Investigational Site
Quezon City

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South Korea8 sites

1235.7.82007 Boehringer Ingelheim Investigational Site
Busan
1235.7.82001 Boehringer Ingelheim Investigational Site
Daegu
1235.7.82006 Boehringer Ingelheim Investigational Site
Daejeon
1235.7.82004 Boehringer Ingelheim Investigational Site
Gangwon-Do
1235.7.82008 Boehringer Ingelheim Investigational Site
Gwangju
1235.7.82002 Boehringer Ingelheim Investigational Site
Seoul
1235.7.82003 Boehringer Ingelheim Investigational Site
Seoul
1235.7.82005 Boehringer Ingelheim Investigational Site
Seoul

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Belgium7 sites

1235.7.32004 Boehringer Ingelheim Investigational Site
Aywaille
1235.7.32010 Boehringer Ingelheim Investigational Site
Gozée
1235.7.32008 Boehringer Ingelheim Investigational Site
Linkebeek
1235.7.32003 Boehringer Ingelheim Investigational Site
Mol
1235.7.32007 Boehringer Ingelheim Investigational Site
Natoye
1235.7.32002 Boehringer Ingelheim Investigational Site
Tienen
1235.7.32005 Boehringer Ingelheim Investigational Site
Turnhout

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Sweden5 sites

1235.7.46002 Boehringer Ingelheim Investigational Site
Gothenburg
1235.7.46003 Boehringer Ingelheim Investigational Site
Gothenburg
1235.7.46005 Boehringer Ingelheim Investigational Site
Luleå
1235.7.46004 Boehringer Ingelheim Investigational Site
Rättvik
1235.7.46001 Boehringer Ingelheim Investigational Site
Stockholm

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Finland4 sites

1235.7.35003 Boehringer Ingelheim Investigational Site
Joensuu
1235.7.35004 Boehringer Ingelheim Investigational Site
Joensuu
1235.7.35001 Boehringer Ingelheim Investigational Site
Turku
1235.7.35002 Boehringer Ingelheim Investigational Site
Turku

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Norway4 sites

1235.7.47001 Boehringer Ingelheim Investigational Site
Ålesund
1235.7.47002 Boehringer Ingelheim Investigational Site
Bergen
1235.7.47003 Boehringer Ingelheim Investigational Site
Hamar
1235.7.47004 Boehringer Ingelheim Investigational Site
Oslo

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Taiwan4 sites

1235.7.88605 Boehringer Ingelheim Investigational Site
Changhua
1235.7.88608 Boehringer Ingelheim Investigational Site
Hualien City
1235.7.88601 Boehringer Ingelheim Investigational Site
Kaohsiung City
1235.7.88603 Boehringer Ingelheim Investigational Site
Taichung

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About this study

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.

Conditions: Hypertension
Being tested: telmisartan/amlodipine 40/5 mg fixed combination, telmisartan/amlodipine 80/5 mg fixed combination
Medical subject headings: Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

telmisartan/amlodipine 40/5 mg fixed combinationDrug
telmisartan/amlodipine 80/5 mg fixed combinationDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

Trough Seated Diastolic Blood Pressure (DBP) Control
The number of patients who reach the target DBP of <90mmHg
Measured: End of study (34 weeks or last value on treatment)

Secondary outcomes (13)

Trough Seated Systolic Blood Pressure (SBP) Control
The number of patients who reach the target SBP of <140mmHg
Measured: End of study (34 weeks or last value on treatment)
Change From Baseline in Trough Seated Diastolic Blood Pressure
Change from baseline to the end of study in trough DBP. Baseline is defined as visit 3 of trial 1235.5.
Measured: End of study (34 weeks or last value on treatment)
Change in DBP From Last Available Trough in 1235.5 to Last Available Trough in 1235.7
The difference between the last available troughs represents the additional reduction in DBP in this study
Measured: End of study (34 weeks or last value on treatment)
Change From Baseline in Trough Seated Systolic Blood Pressure
Change from baseline to the end of study in trough SBP. Baseline is defined as visit 3 of trial 1235.5.
Measured: End of study (34 weeks or last value on treatment)
Change in SBP From Last Available Trough in 1235.5 to Last Available Trough in 1235.7
The difference between the last available troughs represents the additional reduction in SBP in this study
Measured: End of study (34 weeks or last value on treatment)
Trough Seated DBP Response
The number of patients who reach the target DBP of <90mmHg or had a reduction in DBP >= 10mmHg
Measured: End of study (34 weeks or last value on treatment)
Trough Seated SBP Response
The number of patients who reach the target SBP of <140mmHg or had a reduction in SBP >= 15 mmHg
Measured: End of study (34 weeks or last value on treatment)
Trough Blood Pressure (BP) Normality Classes
The number of patients who reach predefined BP categories
Measured: End of study (34 weeks or last value on treatment)
Time to First Additional Antihypertensive
Time from first intake of medication to first intake of an antihypertensive other than the study drug
Measured: At any point during open-label treatment
Patients Requiring Additional Antihypertensive Therapy to Achieve DBP Control
The number of patients with DBP control (DBP<90 mmHg). Last trough DBP measurement before taking additional antihypertensive compared to last trough DBP taken on treatment
Measured: At any point during open-label treatment
Additional Reduction in DBP by Use of Additional Antihypertensive Therapy
Difference in trough DBP from last visit before add-on therapy and last visit during 1235.7
Measured: At any point during open-label treatment
Additional Reduction in SBP by Use of Additional Antihypertensive Therapy
Difference in trough SBP from last visit before add-on therapy and last visit during 1235.7
Measured: At any point during open-label treatment
Trough DBP Control Pre- and Post- Uptitration
The number of patients with DBP control (DBP<90 mmHg). Last trough DBP measurement before uptitration to Telmisartan 80mg compared to first trough DBP taken after uptitration
Measured: At any point during open-label treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2008Mar 2009

First posted13 Feb 2008 (estimated)
Study startJan 2008
Primary completionMar 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HypertensionStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Enrolment: 976 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00614380
Sponsor's protocol ID: 1235.7
Other IDs: EUDRACT2007-002410-19
Status last verified: Dec 2013
First submitted: 28 Jan 2008
Last updated: 13 Feb 2014
Results posted: Yes, on ClinicalTrials.gov

Publications

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.
PubMed 24653513

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 13 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT00614380
Acronym / sponsor ID: 1235.7
Conditions: Hypertension
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 976 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Jan 2008
Primary completion: Mar 2009 (actual)
First posted: 13 Feb 2008 (estimated)
Results: Posted 18 Jan 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (5 listed)

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
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
discontinuation from the preceding trial because of any adverse event or any other reason
known or suspected secondary hypertension
mean seated Systolic Blood Pressure => 180 mmHg and/or mean seated Diastolic Blood Pressure => 120 mmHg at any visit

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
telmisartan/amlodipine 40/5 mg fixed combination	Drug	–
telmisartan/amlodipine 80/5 mg fixed combination	Drug	–

Primary outcome

Trough Seated Diastolic Blood Pressure (DBP) Control
Time frame: End of study (34 weeks or last value on treatment)
The number of patients who reach the target DBP of <90mmHg

13 secondary outcomes

Trough Seated Systolic Blood Pressure (SBP) Control
Time frame: End of study (34 weeks or last value on treatment)
Change From Baseline in Trough Seated Diastolic Blood Pressure
Time frame: End of study (34 weeks or last value on treatment)
Change in DBP From Last Available Trough in 1235.5 to Last Available Trough in 1235.7
Time frame: End of study (34 weeks or last value on treatment)
Change From Baseline in Trough Seated Systolic Blood Pressure
Time frame: End of study (34 weeks or last value on treatment)
Change in SBP From Last Available Trough in 1235.5 to Last Available Trough in 1235.7
Time frame: End of study (34 weeks or last value on treatment)
Trough Seated DBP Response
Time frame: End of study (34 weeks or last value on treatment)
Trough Seated SBP Response
Time frame: End of study (34 weeks or last value on treatment)
Trough Blood Pressure (BP) Normality Classes
Time frame: End of study (34 weeks or last value on treatment)
Time to First Additional Antihypertensive
Time frame: At any point during open-label treatment
Patients Requiring Additional Antihypertensive Therapy to Achieve DBP Control
Time frame: At any point during open-label treatment
Additional Reduction in DBP by Use of Additional Antihypertensive Therapy
Time frame: At any point during open-label treatment
Additional Reduction in SBP by Use of Additional Antihypertensive Therapy
Time frame: At any point during open-label treatment
Trough DBP Control Pre- and Post- Uptitration
Time frame: At any point during open-label treatment

Results and safety

Results posted to the registry on 18 Jan 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Telmisartan 40mg and Amlodipine 5mg	564	529
Telmisartan 80mg and Amlodipine 5mg	206	198
Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive	25	24
Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive	181	179

Primary outcome: Trough Seated Diastolic Blood Pressure (DBP) Control

Time frame: End of study (34 weeks or last value on treatment). Number. Unit: Participants

Measure	Telmisartan 40mg and Amlodipine 5mg n = 553	Telmisartan 80mg and Amlodipine 5mg n = 206	Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive n = 25	Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive n = 181
Yes (DBP<90 mmHg)	504	160	19	84
No (DBP>=90 mmHg)	49	46	6	97

Telmisartan 40mg and Amlodipine 5mg vs Telmisartan 80mg and Amlodipine 5mg: Odds Ratio (OR): 0.34 (95% CI 0.22 to 0.53), Cochran-Mantel-Haenszel
Telmisartan 40mg and Amlodipine 5mg vs Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive: Odds Ratio (OR): 0.31 (95% CI 0.12 to 0.81), Cochran-Mantel-Haenszel
Telmisartan 40mg and Amlodipine 5mg vs Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive: Odds Ratio (OR): 0.08 (95% CI 0.06 to 0.13), Cochran-Mantel-Haenszel

Population analysed: The full analysis set of patients. All patients who took at least one dose of study medication and have at least one on treatment BP measurement 20-30 hours post dose

13 secondary outcomes are reported in the full results.

Adverse events

Time frame: From day of first dose until one day after last dose. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Telmisartan 40mg and Amlodipine 5mg	22 of 976 (2.3%)	57 of 976 (5.8%)	Not reported
Telmisartan 80mg and Amlodipine 5mg	6 of 397 (1.5%)	45 of 397 (11.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 24653513Neldam 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.
Related InfoLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

122 sites in 12 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 122 sites in France, Canada, South Africa, Denmark, Netherlands and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Jan 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Trough Seated Diastolic Blood Pressure (DBP) Control (time frame: End of study (34 weeks or last value on treatment)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00614380, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2014.