HypertensionPhase 3NCT00624052

26-week Open Study of telmisartan40mg+amlodipine10mg or telmisartan80mg+amlodipine10 mg in Hypertension

A Phase 3 study testing fixed-dose combination of telmisartan 40mg+amlodipine 10mg and fixed-dose combination of telmisartan 80mg+amlodipine10mg in people with Hypertension, run by Boehringer Ingelheim at 92 sites in 12 countries.

Completed

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

Official record

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Trial summary

The primary objective of this trial is to assess the efficacy and safety of the fixed dose combinations telmisartan 40mg/amlodipine 10mg (T40/A10) or telmisartan 80mg/amlodipine 10mg (T80/A10) during open-label treatment for at least six months. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hypertension
What is being tested?: fixed-dose combination of telmisartan 40mg+amlodipine 10mg and fixed-dose combination of telmisartan 80mg+amlodipine10mg
How many people: 838 participants
Where: 92 sitesin 12 countries
Study dates: Mar 2008to Jun 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

diagnosis of essential hypertension

Who cannot join

pregnancy, breast-feeding, unwilling to use effective contraception (if female of child-bearing potential).
development of any condition in the preceding trial that could be worsened by telmisartan 40mg/amlodipine 10mg (T40/A10) or telmisartan 80mg/amlodipine 10mg (T80/A10).
discontinuation from the preceding trial.
known or suspected secondary hypertension.
mean seated systolic blood pressure (SBP) >= 180 mmHg and/or mean seated diastolic blood pressure (DBP) >= 120 mmHg at any visit.
any clinically significant hepatic impairment or severe renal impairment bilateral renal artery stenosis or renal artery stenosis in a solitary kidney or post post-renal transplant.

Show all 17Show fewer

clinically relevant hyperkalaemia.
uncorrected volume or sodium depletion.
primary aldosteronism.
hereditary fructose or lactose intolerance.
symptomatic congestive heart failure.
patients who have previously experienced symptoms characteristic of angioedema during treatment with angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs).
any new drug or alcohol dependency since signing consent of the preceding trial.
concurrent participation in another clinical trial or any investigational therapy since completing the preceding trial.
hypertrophic obstructive cardiomyopathy, hemodynamically relevant stenosis of the aortic or mitral valve.
known allergic hypersensitivity to any component of the formulations under investigation. [Includes known hypersensitivity to telmisartan or other ARBs or amlodipine or other dihydropyridine calcium channel blockers (CCBs).] non-compliance with study medication (defined as <80% or >120%) during the preceding trial.
administration of ARBs or dihydropyridine CCBs (apart from trial medication). any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of telmisartan and amlodipine.

Trial locations and contacts

92 sites in 12 countries.

Country

City, postcode or hospital

92 sites in 12 countries

United Kingdom15 sites

1235.8.44010 Boehringer Ingelheim Investigational Site
Bexhill-on-Sea
1235.8.44008 Boehringer Ingelheim Investigational Site
Blackpool
1235.8.44016 Boehringer Ingelheim Investigational Site
Blackpool
1235.8.44011 Boehringer Ingelheim Investigational Site
Burbage
1235.8.44007 Boehringer Ingelheim Investigational Site
Chestfield, Whitstable
1235.8.44005 Boehringer Ingelheim Investigational Site
Chorley
1235.8.44002 Boehringer Ingelheim Investigational Site
Edgbaston, Birmingham
1235.8.44009 Boehringer Ingelheim Investigational Site
Ely
1235.8.44001 Boehringer Ingelheim Investigational Site
Fowey
1235.8.44003 Boehringer Ingelheim Investigational Site
Glasgow
1235.8.44012 Boehringer Ingelheim Investigational Site
Penzance
1235.8.44013 Boehringer Ingelheim Investigational Site
Plymouth
1235.8.44004 Boehringer Ingelheim Investigational Site
Reading
1235.8.44015 Boehringer Ingelheim Investigational Site
St Austell
1235.8.44006 Boehringer Ingelheim Investigational Site
Whitstable

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Ukraine13 sites

1235.8.38010 Boehringer Ingelheim Investigational Site
Dnipro
1235.8.38001 Boehringer Ingelheim Investigational Site
Kharkiv
1235.8.38003 Boehringer Ingelheim Investigational Site
Kharkiv
1235.8.38008 Boehringer Ingelheim Investigational Site
Kharkiv
1235.8.38011 Boehringer Ingelheim Investigational Site
Kharkiv
1235.8.38004 Boehringer Ingelheim Investigational Site
Kiev
1235.8.38006 Boehringer Ingelheim Investigational Site
Kiev
1235.8.38012 Boehringer Ingelheim Investigational Site
Kiev
1235.8.38013 Boehringer Ingelheim Investigational Site
Kiev
1235.8.38002 Boehringer Ingelheim Investigational Site
Lviv
1235.8.38005 Boehringer Ingelheim Investigational Site
Odesa
1235.8.38009 Boehringer Ingelheim Investigational Site
Odesa
1235.8.38007 Boehringer Ingelheim Investigational Site
Zaporizhzhya

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Spain11 sites

1235.8.34008 Boehringer Ingelheim Investigational Site
Badalona
1235.8.34010 Boehringer Ingelheim Investigational Site
Badalona
1235.8.34009 Boehringer Ingelheim Investigational Site
Barcelona
1235.8.34001 Boehringer Ingelheim Investigational Site
Jerez de La Frontera (Cádiz)
1235.8.34006 Boehringer Ingelheim Investigational Site
L'Hospitalet de Llobregat (Barcelona)
1235.8.34003 Boehringer Ingelheim Investigational Site
Madrid
1235.8.34004 Boehringer Ingelheim Investigational Site
Madrid
1235.8.34012 Boehringer Ingelheim Investigational Site
Mataró
1235.8.34002 Boehringer Ingelheim Investigational Site
Oviedo
1235.8.34005 Boehringer Ingelheim Investigational Site
Santa Coloma de Gramanet
1235.8.34011 Boehringer Ingelheim Investigational Site
Santa Coloma de Gramanet

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Bulgaria9 sites

1235.8.35912 Boehringer Ingelheim Investigational Site
Burgas
1235.8.35902 Boehringer Ingelheim Investigational Site
Sofia
1235.8.35903 Boehringer Ingelheim Investigational Site
Sofia
1235.8.35904 Boehringer Ingelheim Investigational Site
Sofia
1235.8.35905 Boehringer Ingelheim Investigational Site
Sofia
1235.8.35906 Boehringer Ingelheim Investigational Site
Sofia
1235.8.35907 Boehringer Ingelheim Investigational Site
Sofia
1235.8.35910 Boehringer Ingelheim Investigational Site
Sofia
1235.8.35911 Boehringer Ingelheim Investigational Site
Sofia

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Russia9 sites

1235.8.70004 Boehringer Ingelheim Investigational Site
Moscow
1235.8.70005 Boehringer Ingelheim Investigational Site
Moscow
1235.8.70006 Boehringer Ingelheim Investigational Site
Moscow
1235.8.70007 Boehringer Ingelheim Investigational Site
Moscow
1235.8.70008 Boehringer Ingelheim Investigational Site
Moscow
1235.8.70009 Boehringer Ingelheim Investigational Site
Moscow
1235.8.70010 Boehringer Ingelheim Investigational Site
Saint Petersburg
1235.8.70011 Boehringer Ingelheim Investigational Site
Saint Petersburg
1235.8.70012 Boehringer Ingelheim Investigational Site
Saint Petersburg

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Czechia7 sites

1235.8.42002 Boehringer Ingelheim Investigational Site
Benátky nad Jizerou
1235.8.42006 Boehringer Ingelheim Investigational Site
Brno
1235.8.42001 Boehringer Ingelheim Investigational Site
Pilsen
1235.8.42003 Boehringer Ingelheim Investigational Site
Prague
1235.8.42004 Boehringer Ingelheim Investigational Site
Příbram
1235.8.42005 Boehringer Ingelheim Investigational Site
Slaný
1235.8.42007 Boehringer Ingelheim Investigational Site
Strakonice

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Slovakia7 sites

1235.8.42103 Boehringer Ingelheim Investigational Site
Dolný Kubín
1235.8.42106 Boehringer Ingelheim Investigational Site
Kralovsky Chmlec
1235.8.42104 Boehringer Ingelheim Investigational Site
Liptovský Mikuláš
1235.8.42102 Boehringer Ingelheim Investigational Site
Považská Bystrica
1235.8.42105 Boehringer Ingelheim Investigational Site
Prešov
1235.8.42101 Boehringer Ingelheim Investigational Site
Trenčín
1235.8.42107 Boehringer Ingelheim Investigational Site
Vráble

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Australia5 sites

1235.8.61005 Boehringer Ingelheim Investigational Site
Elizabeth Vale, South Australia
1235.8.61003 Boehringer Ingelheim Investigational Site
Gosford, New South Wales
1235.8.61002 Boehringer Ingelheim Investigational Site
Kippa-Ring, Queensland
1235.8.61004 Boehringer Ingelheim Investigational Site
Liverpool, New South Wales
1235.8.61001 Boehringer Ingelheim Investigational Site
Milton, Queensland

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Austria5 sites

1235.8.43007 Boehringer Ingelheim Investigational Site
Eggenburg
1235.8.43006 Boehringer Ingelheim Investigational Site
Hainburg A.d. Donau
1235.8.43001 Boehringer Ingelheim Investigational Site
Vienna
1235.8.43002 Boehringer Ingelheim Investigational Site
Vienna
1235.8.43003 Boehringer Ingelheim Investigational Site
Vienna

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Ireland5 sites

1235.8.35304 Boehringer Ingelheim Investigational Site
Birr
1235.8.35305 Boehringer Ingelheim Investigational Site
Carrigtowhill
1235.8.35303 Boehringer Ingelheim Investigational Site
Gorey, Co. Wexford
1235.8.35306 Boehringer Ingelheim Investigational Site
Mallow
1235.8.35301 Boehringer Ingelheim Investigational Site
New Ross

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Italy3 sites

1235.8.39002 Boehringer Ingelheim Investigational Site
Broni (pv)
1235.8.39006 Boehringer Ingelheim Investigational Site
Coppito (AQ)
1235.8.39001 Boehringer Ingelheim Investigational Site
Ferrara

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New Zealand3 sites

1235.8.64003 Boehringer Ingelheim Investigational Site
Dunedin
1235.8.64002 Boehringer Ingelheim Investigational Site
Otahuhu, Auckland
1235.8.64001 Boehringer Ingelheim Investigational Site
Tauranga

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About this study

Official title: An Open Label Trial of the Efficacy and Safety of Chronic Administration of the Fixed Dose Combination of Telmisartan 40mg + Amlodipine 10mg or Fixed Dose Combination of Telmisartan 80mg + Amlodipine 10mg Tablets Alone or in Combination With Other Antihypertensive Medications in Patients With Hypertension

An additional objective is to assess the efficacy and safety of concomitant administration of either T40/A10 or T80/A10 with any other therapies commonly used in the treatment of hypertension.

The primary endpoint is the proportion of patients achieving DBP control (defined as mean seated DBP < 90 mmHg at trough i.e. approximately 24 hours after last dose of study treatment) at six months of treatment or at last trough observation during the treatment period (i.e. last trough observation carried forward).

Conditions: Hypertension
Being tested: fixed-dose combination of telmisartan 40mg+amlodipine 10mg, fixed-dose combination of telmisartan 80mg+amlodipine10mg
Medical subject headings: Hypertension

What participants receive

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

fixed-dose combination of telmisartan 40mg+amlodipine 10mgDrug
fixed-dose combination of telmisartan 80mg+amlodipine10mgDrug

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 reached 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 reached the target SBP of >=140mmHg
Measured: End of study (34 weeks or last value on treatment)
Change From Baseline to End of Study 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 1235.6
Measured: Baseline is defined as visit 3 of study NCT00553267 and end of study as 34 weeks or last value on treatment
Change in DBP From Last Available Trough in NCT00553267 to Last Available Trough in NCT00624052
The difference between the last available troughs represents the additional reduction in DBP in this study
Measured: Last available trough in NCT00553267 to end of study (34 weeks or last value on treatment)
Change From Baseline to End of Study 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 1235.6
Measured: Baseline is defined as visit 3 of study NCT00553267 and end of study as 34 weeks or last value on treatment
Change in SBP From Last Available Trough in NCT00553267 to Last Available Trough in NCT00624052
The difference between the last available troughs represents the additional reduction in SBP in this study
Measured: Last available trough in NCT00624052 to 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 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: up to 34 weeks
Number of 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: up to 34 weeks
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 NCT00624052
Measured: up to 34 weeks
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 NCT00624052
Measured: up to 34 weeks
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 and amlodipine 10mg compared to first trough DBP taken after uptitration. Uptitration could be based DBP>90 or investigator opinion.
Measured: up to 34 weeks

Timeline

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

Mar 2008Jun 2009

First posted26 Feb 2008 (estimated)
Study startMar 2008
Primary completionJun 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: 838 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00624052
Sponsor's protocol ID: 1235.8
Status last verified: May 2014
First submitted: 5 Feb 2008
Last updated: 20 May 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?

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Study at a glance

From the registry record, last updated by the sponsor on 20 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open Label Trial of the Efficacy and Safety of Chronic Administration of the Fixed Dose Combination of Telmisartan 40mg + Amlodipine 10mg or Fixed Dose Combination of Telmisartan 80mg + Amlodipine 10mg Tablets Alone or in Combination With Other Antihypertensive Medications in Patients With Hypertension
ClinicalTrials.gov ID: NCT00624052
Acronym / sponsor ID: 1235.8
Conditions: Hypertension
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 838 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Mar 2008
Primary completion: Jun 2009 (actual)
First posted: 26 Feb 2008 (estimated)
Results: Posted 25 Mar 2010

Clinical summary

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

An additional objective is to assess the efficacy and safety of concomitant administration of either T40/A10 or T80/A10 with any other therapies commonly used in the treatment of hypertension.

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 (1 listed)

diagnosis of essential hypertension

Key exclusion criteria (17 listed)

pregnancy, breast-feeding, unwilling to use effective contraception (if female of child-bearing potential).
development of any condition in the preceding trial that could be worsened by telmisartan 40mg/amlodipine 10mg (T40/A10) or telmisartan 80mg/amlodipine 10mg (T80/A10).
discontinuation from the preceding trial.
known or suspected secondary hypertension.
mean seated systolic blood pressure (SBP) >= 180 mmHg and/or mean seated diastolic blood pressure (DBP) >= 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
fixed-dose combination of telmisartan 40mg+amlodipine 10mg	Drug	–
fixed-dose combination of telmisartan 80mg+amlodipine10mg	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 reached 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 to End of Study in Trough Seated Diastolic Blood Pressure
Time frame: Baseline is defined as visit 3 of study NCT00553267 and end of study as 34 weeks or last value on treatment
Change in DBP From Last Available Trough in NCT00553267 to Last Available Trough in NCT00624052
Time frame: Last available trough in NCT00553267 to end of study (34 weeks or last value on treatment)
Change From Baseline to End of Study in Trough Seated Systolic Blood Pressure
Time frame: Baseline is defined as visit 3 of study NCT00553267 and end of study as 34 weeks or last value on treatment
Change in SBP From Last Available Trough in NCT00553267 to Last Available Trough in NCT00624052
Time frame: Last available trough in NCT00624052 to 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 BP Normality Classes
Time frame: End of study (34 weeks or last value on treatment)
Time to First Additional Antihypertensive
Time frame: up to 34 weeks
Number of Patients Requiring Additional Antihypertensive Therapy to Achieve DBP Control
Time frame: up to 34 weeks
Additional Reduction in DBP by Use of Additional Antihypertensive Therapy
Time frame: up to 34 weeks
Additional Reduction in SBP by Use of Additional Antihypertensive Therapy
Time frame: up to 34 weeks
Trough DBP Control Pre- and Post- Uptitration
Time frame: up to 34 weeks

Results and safety

Results posted to the registry on 25 Mar 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 10mg	219	204
Randomised Telmisartan 80mg and Amlodipine 10mg	436	422
Titrated Telmisartan 80mg and Amlodipine 10mg	91	88
Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on	92	88

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

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

Measure	Telmisartan 40mg and Amlodipine 10mg n = 216	Randomised Telmisartan 80mg and Amlodipine 10mg n = 436	Titrated Telmisartan 80mg and Amlodipine 10mg n = 91	Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on n = 92
Yes (DBP<90 mmHg)	201	402	72	70
No (DBP>=90 mmHg)	15	34	19	22

Telmisartan 40mg and Amlodipine 10mg vs Randomised Telmisartan 80mg and Amlodipine 10mg: Odds Ratio (OR): 0.88 (95% CI 0.47 to 1.66), Cochran-Mantel-Haenszel
Telmisartan 40mg and Amlodipine 10mg vs Titrated Telmisartan 80mg and Amlodipine 10mg: Odds Ratio (OR): 0.28 (95% CI 0.14 to 0.59), Cochran-Mantel-Haenszel
Telmisartan 40mg and Amlodipine 10mg vs Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on: Odds Ratio (OR): 0.24 (95% CI 0.12 to 0.48), 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 through to the 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 10mg	4 of 838 (0.5%)	0 of 838 (0%)	Not reported
Telmisartan 80mg and Amlodipine 10mg	13 of 611 (2.1%)	0 of 611 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 May 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.
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

92 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 1 inclusion and 17 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 20 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 92 sites in United Kingdom, Ukraine, Spain, Bulgaria, Russia 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 25 Mar 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 NCT00624052, 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 20 May 2014.