HypertensionPhase 3NCT00558428

Telmisartan/Amlodipine (80/5) vs. Telmisartan/Amlodipine (40/5) vs. Amlodipine 10 or 5 in Resistant Hypertension

A Phase 3 study testing fixed dose combination of telmisartan+amlodipine and amlodipine in people with Hypertension, run by Boehringer Ingelheim at 129 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

Who is it for?: Ages 18 years and older
Conditions the study is for: Hypertension
What is being tested?: fixed dose combination of telmisartan+amlodipine and amlodipine
How many people: 1,098 participants
Where: 129 sitesin 12 countries
Study dates: Oct 2007to Sep 2008
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 at the date of signing the consent form
diagnosis of essential hypertension and blood pressure not adequately controlled before enrolment in the study
failure to respond adequately to six weeks treatment with amlodipine 5 mg monotherapy
able to stop any current antihypertensive therapy without unacceptable risk to the patient (Investigator's decision)
willing and able to provide written informed consent (in accordance with Good Clinical Practice and local legislation).

Who cannot join

are not practising acceptable means of birth control or do not plan to continue using acceptable means of birth control throughout the study and do not agree to submit to pregnancy testing during participation in the trial. Acceptable methods of birth control include the transdermal patch, oral, implantable or injectable contraceptives, sexual abstinence and vasectomised partner.
known or suspected secondary hypertension
mean seated systolic blood pressure (SBP) over 200 mmHg and/or mean seated diastolic blood pressure (DBP) over 120 mmHg at Visit 1 or 2 or mean seated SBP over 180 mmHg and/or mean seated DBP over 120 mmHg at the end of the run-in period (Visit 3)
any clinically significant hepatic impairment (e.g. clinically significant cholestasis, biliary obstructive disorder or hepatic insufficiency)
severe renal impairment (e.g. serum creatinine >3.0 mg/dL or >265 mcmol/L, known creatinine clearance <30mL/min or clinical markers of severe renal impairment)
bilateral renal artery stenosis or renal artery stenosis in a solitary kidney or post-renal transplant

Show all 10Show fewer

clinically relevant hyperkalaemia
uncorrected volume or sodium depletion.
primary aldosteronism.
hereditary fructose or lactose intolerance

Trial locations and contacts

129 sites in 12 countries.

Country

City, postcode or hospital

129 sites in 12 countries

France50 sites

1235.5.3301H Boehringer Ingelheim Investigational Site
Aigrefeuille S/Maine
1235.5.3306C Boehringer Ingelheim Investigational Site
Angers
1235.5.3309B Boehringer Ingelheim Investigational Site
Angers
1235.5.3309C Boehringer Ingelheim Investigational Site
Angers
1235.5.3309E Boehringer Ingelheim Investigational Site
Angers
1235.5.3309D Boehringer Ingelheim Investigational Site
Avrillé
1235.5.3309A Boehringer Ingelheim Investigational Site
Beaucouzé
1235.5.3303B Boehringer Ingelheim Investigational Site
Bono
1235.5.3305A Boehringer Ingelheim Investigational Site
Bourg Des Cptes
1235.5.3306D Boehringer Ingelheim Investigational Site
Briollay
1235.5.3308B Boehringer Ingelheim Investigational Site
Cholet
1235.5.3308C Boehringer Ingelheim Investigational Site
Cholet
1235.5.3308D Boehringer Ingelheim Investigational Site
Cholet
1235.5.3308F Boehringer Ingelheim Investigational Site
Cholet
1235.5.3302C Boehringer Ingelheim Investigational Site
Garchizy
1235.5.3303C Boehringer Ingelheim Investigational Site
Grandchamps
1235.5.3302D Boehringer Ingelheim Investigational Site
Guérigny
1235.5.3310A Boehringer Ingelheim Investigational Site
Jarny
1235.5.3301L Boehringer Ingelheim Investigational Site
La Chapelle /s Erdre
1235.5.3301J Boehringer Ingelheim Investigational Site
La Chapelle-sur-Erdre
1235.5.3304A Boehringer Ingelheim Investigational Site
La Fresnais
1235.5.3308E Boehringer Ingelheim Investigational Site
La Jubaudière
1235.5.3301G Boehringer Ingelheim Investigational Site
La Montagne
1235.5.3307D Boehringer Ingelheim Investigational Site
Le Mesnil-en-Vallée
1235.5.3301E Boehringer Ingelheim Investigational Site
Le Temple-de-Bretagne
1235.5.3309F Boehringer Ingelheim Investigational Site
Les Ponts-de-Cé
1235.5.3307G Boehringer Ingelheim Investigational Site
Loudun
1235.5.3305B Boehringer Ingelheim Investigational Site
Louvigné Le Bais
1235.5.3307E Boehringer Ingelheim Investigational Site
Mouliherne
1235.5.3306A Boehringer Ingelheim Investigational Site
Mûrs-Erigné
1235.5.3307A Boehringer Ingelheim Investigational Site
Mûrs-Erigné
1235.5.3301A Boehringer Ingelheim Investigational Site
Nantes
1235.5.3301B Boehringer Ingelheim Investigational Site
Nantes
1235.5.3301D Boehringer Ingelheim Investigational Site
Nantes
1235.5.3301M Boehringer Ingelheim Investigational Site
Nantes
1235.5.3302A Boehringer Ingelheim Investigational Site
Nevers
1235.5.3302F Boehringer Ingelheim Investigational Site
Nevers
1235.5.3301I Boehringer Ingelheim Investigational Site
Nort-sur-Erdre
1235.5.3301C Boehringer Ingelheim Investigational Site
Orvault
1235.5.3307F Boehringer Ingelheim Investigational Site
Parçay-les-Pins
1235.5.3301F Boehringer Ingelheim Investigational Site
Saint Aubin Les Châteaux
1235.5.3306F Boehringer Ingelheim Investigational Site
Saint-Georges-de-Montaigu
1235.5.3304B Boehringer Ingelheim Investigational Site
Saint-Ouen-la-Rouërie
1235.5.3307C Boehringer Ingelheim Investigational Site
Saint-Pierre-Montlimart
1235.5.3301N Boehringer Ingelheim Investigational Site
Sautron
1235.5.3306B Boehringer Ingelheim Investigational Site
Segré
1235.5.3306E Boehringer Ingelheim Investigational Site
Thouars
1235.5.3304C Boehringer Ingelheim Investigational Site
Tinténiac
1235.5.3303A Boehringer Ingelheim Investigational Site
Vannes
1235.5.3308A Boehringer Ingelheim Investigational Site
Vihiers

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Canada12 sites

1235.5.20007 Boehringer Ingelheim Investigational Site
Bay Roberts, Newfoundland and Labrador
1235.5.20001 Boehringer Ingelheim Investigational Site
Coquitlam, British Columbia
1235.5.20013 Boehringer Ingelheim Investigational Site
Corunna, Ontario
1235.5.20014 Boehringer Ingelheim Investigational Site
Etobicoke, Ontario
1235.5.20010 Boehringer Ingelheim Investigational Site
Hamilton, Ontario
1235.5.20012 Boehringer Ingelheim Investigational Site
London, Ontario
1235.5.20005 Boehringer Ingelheim Investigational Site
Mount Pearl, Newfoundland and Labrador
1235.5.20009 Boehringer Ingelheim Investigational Site
Ottawa, Ontario
1235.5.20003 Boehringer Ingelheim Investigational Site
Sainte-Foy, Quebec
1235.5.20006 Boehringer Ingelheim Investigational Site
Sarnia, Ontario
1235.5.20008 Boehringer Ingelheim Investigational Site
St. John's, Newfoundland and Labrador
1235.5.20011 Boehringer Ingelheim Investigational Site
Vancouver, British Columbia

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Belgium9 sites

1235.5.32004 Boehringer Ingelheim Investigational Site
Aywaille
1235.5.32001 Boehringer Ingelheim Investigational Site
Brussels
1235.5.32010 Boehringer Ingelheim Investigational Site
Gozée
1235.5.32008 Boehringer Ingelheim Investigational Site
Linkebeek
1235.5.32003 Boehringer Ingelheim Investigational Site
Mol
1235.5.32007 Boehringer Ingelheim Investigational Site
Natoye
1235.5.32009 Boehringer Ingelheim Investigational Site
Tavier
1235.5.32002 Boehringer Ingelheim Investigational Site
Tienen-Kumtich
1235.5.32005 Boehringer Ingelheim Investigational Site
Turnhout

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South Africa9 sites

1235.5.27003 Boehringer Ingelheim Investigational Site
Boksburg
1235.5.27006 Boehringer Ingelheim Investigational Site
Cape Town
1235.5.27009 Boehringer Ingelheim Investigational Site
Cape Town
1235.5.27010 Boehringer Ingelheim Investigational Site
Cape Town
1235.5.27004 Boehringer Ingelheim Investigational Site
Durban
1235.5.27008 Boehringer Ingelheim Investigational Site
Johannesburg
1235.5.27001 Boehringer Ingelheim Investigational Site
Krugersdorp
1235.5.27005 Boehringer Ingelheim Investigational Site
Lenasia
1235.5.27002 Boehringer Ingelheim Investigational Site
Pretoria

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Denmark8 sites

1235.5.45002 Boehringer Ingelheim Investigational Site
Birkerød
1235.5.45005 Boehringer Ingelheim Investigational Site
Haderslev
1235.5.45008 Boehringer Ingelheim Investigational Site
Herning
1235.5.45009 Boehringer Ingelheim Investigational Site
Hinnerup
1235.5.45001 Boehringer Ingelheim Investigational Site
Rødovre Municipality
1235.5.45006 Boehringer Ingelheim Investigational Site
Rødovre Municipality
1235.5.45003 Boehringer Ingelheim Investigational Site
Vaerløse
1235.5.45007 Boehringer Ingelheim Investigational Site
Vildbjerg

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Netherlands8 sites

1235.5.31008 Boehringer Ingelheim Investigational Site
Beerzerveld
1235.5.31006 Boehringer Ingelheim Investigational Site
Bennebroek
1235.5.31004 Boehringer Ingelheim Investigational Site
Hoogwoud
1235.5.31003 Boehringer Ingelheim Investigational Site
Musselkanaal
1235.5.31007 Boehringer Ingelheim Investigational Site
Nijverdal
1235.5.31001 Boehringer Ingelheim Investigational Site
Oude Pekela
1235.5.31005 Boehringer Ingelheim Investigational Site
Roelofarendsveen
1235.5.31010 Boehringer Ingelheim Investigational Site
Voerendaal

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Philippines8 sites

1235.5.63006 Boehringer Ingelheim Investigational Site
Makati City
1235.5.63001 Boehringer Ingelheim Investigational Site
Manila
1235.5.63002 Boehringer Ingelheim Investigational Site
Manila
1235.5.63009 Boehringer Ingelheim Investigational Site
Manila
1235.5.63008 Boehringer Ingelheim Investigational Site
Pasay
1235.5.63005 Boehringer Ingelheim Investigational Site
Pasig
1235.5.63003 Boehringer Ingelheim Investigational Site
Quezon City
1235.5.63007 Boehringer Ingelheim Investigational Site
Quezon City

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South Korea8 sites

1235.5.82007 Boehringer Ingelheim Investigational Site
Busan
1235.5.82001 Boehringer Ingelheim Investigational Site
Daegu
1235.5.82006 Boehringer Ingelheim Investigational Site
Daejeon
1235.5.82004 Boehringer Ingelheim Investigational Site
Gangwon-Do
1235.5.82008 Boehringer Ingelheim Investigational Site
Gwangju
1235.5.82002 Boehringer Ingelheim Investigational Site
Seoul
1235.5.82003 Boehringer Ingelheim Investigational Site
Seoul
1235.5.82005 Boehringer Ingelheim Investigational Site
Seoul

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Sweden5 sites

1235.5.46002 Boehringer Ingelheim Investigational Site
Gothenburg
1235.5.46003 Boehringer Ingelheim Investigational Site
Gothenburg
1235.5.46005 Boehringer Ingelheim Investigational Site
Luleå
1235.5.46004 Boehringer Ingelheim Investigational Site
Rättvik
1235.5.46001 Boehringer Ingelheim Investigational Site
Stockholm

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Finland4 sites

1235.5.35003 Boehringer Ingelheim Investigational Site
Joensuu
1235.5.35004 Boehringer Ingelheim Investigational Site
Joensuu
1235.5.35001 Boehringer Ingelheim Investigational Site
Turku
1235.5.35002 Boehringer Ingelheim Investigational Site
Turku

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Norway4 sites

1235.5.47001 Boehringer Ingelheim Investigational Site
Ålesund
1235.5.47002 Boehringer Ingelheim Investigational Site
Bergen
1235.5.47003 Boehringer Ingelheim Investigational Site
Hamar
1235.5.47004 Boehringer Ingelheim Investigational Site
Oslo

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Taiwan4 sites

1235.5.88605 Boehringer Ingelheim Investigational Site
Changhua
1235.5.88608 Boehringer Ingelheim Investigational Site
Hualien City
1235.5.88601 Boehringer Ingelheim Investigational Site
Kaohsiung City
1235.5.88603 Boehringer Ingelheim Investigational Site
Taichung

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About this study

Official title: An Eight-week Randomized, 4-arm, Double-blind Study to Compare the Efficacy and Safety of Combinations of Telmisartan 40mg + Amlodipine 5mg Versus Telmisartan 80mg + Amlodipine 5mg Versus Amlodipine 5mg Versus Amlodipine 10mg Monotherapy in Patients With Hypertension Who Fail to Respond Adequately to Treatment With Amlodipine 5mg Monotherapy

The primary objectives of this trial are (a) to demonstrate that the fixed-dose combination T40/A5 or the fixed-dose combination T80/A5 is superior in reducing blood pressure at eight weeks compared with A5 (b) to demonstrate that the fixed-dose combination T40/A5 or the fixed-dose combination T80/A5 is not inferior in reducing blood pressure at eight weeks compared with A10 and (c) to demonstrate that the incidence of oedema on the fixed-dose combination T40/A5 pooled with the fixed-dose combination T80/A5 is superior (less oedema) to A10 in patients who fail to respond adequately to six weeks treatment with A5.

Conditions: Hypertension
Being tested: fixed dose combination of telmisartan+amlodipine, amlodipine
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+amlodipineDrug
amlodipineDrug

What is being measured

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

Change From Baseline in Trough Seated Diastolic Blood Pressure (DBP)
Change from baseline to the end of study in trough DBP
Measured: End of study (8 weeks or last value on treatment)
Number of Patients With Oedema
Patients from the treated set who experienced at least one case of general oedema.
Measured: During randomised treatment period (8 weeks was the planned end of treatment, some of the measurements analysed as end of study can be at 4 weeks or at any point on randomised treatment)

Secondary outcomes (6)

Change From Baseline in Trough Seated Systolic Blood Pressure (SBP)
Change from baseline to the end of study in trough SBP
Measured: End of study (8 weeks or last value on treatment)
Trough Seated Diastolic Blood Pressure Control
The number of patients who reach the target DBP of <90mmHg
Measured: End of study (8 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 (8 weeks or last value on treatment)
Trough Seated SBP Control
The number of patients who reach the target SBP of <140mmHg
Measured: End of study (8 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 (8 weeks or last value on treatment)
Trough Seated Blood Pressure (BP) Normality Classes
The number of patients who reach predefined BP categories:
- Optimal - SBP<120 and DBP<80 mmHg
- Normal - SBP<130 and DBP<85 mmHg
- High-normal - SBP<140 DBP<90 mmHg
- Stage 1 hypertension - SBP<160 and DBP<100
- Stage 2 hypertension SBP>=160 and DBP>=100 mmHg
Measured: End of study (8 weeks or last value on treatment)

Timeline

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

Oct 2007Sep 2008

First posted15 Nov 2007 (estimated)
Study startOct 2007
Primary completionSep 2008

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.
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
Intervention model: Parallel groups
Enrolment: 1,098 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00558428
Sponsor's protocol ID: 1235.5
Other IDs: EUDRACT2007-002409-36
Status last verified: May 2014
First submitted: 29 Oct 2007
Last updated: 27 Jun 2014
Results posted: Yes, on ClinicalTrials.gov

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 27 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Eight-week Randomized, 4-arm, Double-blind Study to Compare the Efficacy and Safety of Combinations of Telmisartan 40mg + Amlodipine 5mg Versus Telmisartan 80mg + Amlodipine 5mg Versus Amlodipine 5mg Versus Amlodipine 10mg Monotherapy in Patients With Hypertension Who Fail to Respond Adequately to Treatment With Amlodipine 5mg Monotherapy
ClinicalTrials.gov ID: NCT00558428
Acronym / sponsor ID: 1235.5
Conditions: Hypertension
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,098 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Oct 2007
Primary completion: Sep 2008 (actual)
First posted: 15 Nov 2007 (estimated)
Results: Posted 15 Dec 2009

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
Intervention model: Parallel groups

Who may qualify

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

Key inclusion criteria (5 listed)

patients aged at least 18 years at the date of signing the consent form
diagnosis of essential hypertension and blood pressure not adequately controlled before enrolment in the study
failure to respond adequately to six weeks treatment with amlodipine 5 mg monotherapy
able to stop any current antihypertensive therapy without unacceptable risk to the patient (Investigator's decision)
willing and able to provide written informed consent (in accordance with Good Clinical Practice and local legislation).

Key exclusion criteria (10 listed)

are not practising acceptable means of birth control or do not plan to continue using acceptable means of birth control throughout the study and do not agree to submit to pregnancy testing during participation in the trial. Acceptable methods of birth control include the transdermal patch, oral, implantable or injectable contraceptives, sexual abstinence and vasectomised partner.
known or suspected secondary hypertension
mean seated systolic blood pressure (SBP) over 200 mmHg and/or mean seated diastolic blood pressure (DBP) over 120 mmHg at Visit 1 or 2 or mean seated SBP over 180 mmHg and/or mean seated DBP over 120 mmHg at the end of the run-in period (Visit 3)
any clinically significant hepatic impairment (e.g. clinically significant cholestasis, biliary obstructive disorder or hepatic insufficiency)
severe renal impairment (e.g. serum creatinine >3.0 mg/dL or >265 mcmol/L, known creatinine clearance <30mL/min or clinical markers of severe renal impairment)

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+amlodipine	Drug	–
amlodipine	Drug	–

Primary outcome

Change From Baseline in Trough Seated Diastolic Blood Pressure (DBP)
Time frame: End of study (8 weeks or last value on treatment)
Change from baseline to the end of study in trough DBP
Number of Patients With Oedema
Time frame: During randomised treatment period (8 weeks was the planned end of treatment, some of the measurements analysed as end of study can be at 4 weeks or at any point on randomised treatment)
Patients from the treated set who experienced at least one case of general oedema.

6 secondary outcomes

Change From Baseline in Trough Seated Systolic Blood Pressure (SBP)
Time frame: End of study (8 weeks or last value on treatment)
Trough Seated Diastolic Blood Pressure Control
Time frame: End of study (8 weeks or last value on treatment)
Trough Seated DBP Response
Time frame: End of study (8 weeks or last value on treatment)
Trough Seated SBP Control
Time frame: End of study (8 weeks or last value on treatment)
Trough Seated SBP Response
Time frame: End of study (8 weeks or last value on treatment)
Trough Seated Blood Pressure (BP) Normality Classes
Time frame: End of study (8 weeks or last value on treatment)

Results and safety

Results posted to the registry on 15 Dec 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Amlodipine 5mg	267	255
Amlodipine 10mg	276	252
Telmisartan 40mg and Amlodipine 5mg	277	273
Telmisartan 80mg and Amlodipine 5mg	277	266

Primary outcome: Change From Baseline in Trough Seated Diastolic Blood Pressure (DBP)

Time frame: End of study (8 weeks or last value on treatment). Least squares mean (Standard Error). Unit: mmHg

Measure	Amlodipine 5mg n = 255	Amlodipine 10mg n = 261	Telmisartan 40mg and Amlodipine 5mg n = 270	Telmisartan 80mg and Amlodipine 5mg n = 271
Value	-5.71 (0.49)	-7.95 (0.49)	-9.35 (0.48)	-10.63 (0.48)

Amlodipine 5mg vs Telmisartan 40mg and Amlodipine 5mg: Least Squares Mean Difference: -3.64 (95% CI -4.90 to -2.38), p <0.0001, ANCOVA
Amlodipine 5mg vs Telmisartan 80mg and Amlodipine 5mg: Least Squares Mean Difference: -4.92 (95% CI -6.18 to -3.66), p <0.0001, ANCOVA
Amlodipine 10mg vs Telmisartan 40mg and Amlodipine 5mg: Least Squares Mean Difference: -1.40 (95% CI -2.66 to -0.14), ANCOVA

Population analysed: Full analysis set of patients who had a baseline trough blood pressure measurement and at least one post baseline trough blood pressure measurement using last observation carried forward. The full analysis set included patients who had baseline and at least one post baseline trough measure of blood pressure

Primary outcome: Number of Patients With Oedema

Time frame: During randomised treatment period (8 weeks was the planned end of treatment, some of the measurements analysed as end of study can be at 4 weeks or at any point on randomised treatment). Number. Unit: patients

Measure	Amlodipine 5mg n = 255	Amlodipine 10mg n = 261	Telmisartan 40mg and Amlodipine 5mg n = 270	Telmisartan 80mg and Amlodipine 5mg n = 271
Number of patients with any oedema	23	76	14	10
Number of patients with general oedema	23	75	14	10

Population analysed: The treated set (TS) consisted of all patients that took at least one dose of the double-blind treatment (n=1097)

6 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
Amlodipine 5mg	2 of 267 (0.7%)	22 of 267 (8.2%)	Not reported
Amlodipine 10mg	1 of 276 (0.4%)	74 of 276 (26.8%)	Not reported
Telmisartan 40mg and Amlodipine 5mg	2 of 277 (0.7%)	14 of 277 (5.1%)	Not reported
Telmisartan 80mg and Amlodipine 5mg	1 of 277 (0.4%)	10 of 277 (3.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing fixed dose combination of telmisartan+amlodipine and amlodipine in people with Hypertension, run by Boehringer Ingelheim at 129 sites in 12 countries.

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 5 inclusion and 10 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 27 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 129 sites in France, Canada, Belgium, South Africa, Denmark 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 15 Dec 2009). 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?

Change From Baseline in Trough Seated Diastolic Blood Pressure (DBP) (time frame: End of study (8 weeks or last value on treatment)). The study lists 2 primary outcomes in all. 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 NCT00558428.

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 27 Jun 2014.