HypertensionPhase 3NCT01134393

TElmisartan and AMlodipine Single Pill sTudy With Patients Not on Goal With Mono rAas Therapy-switch

A Phase 3 study testing telmisartan/amlodipine in people with Hypertension, run by Boehringer Ingelheim at 47 sites in 5 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 general aim of this trial to determine the efficacy as measured by the percentage of patients reaching blood pressure goal at the end of the treatment period at 12 weeks. In-clinic blood pressures, home blood pressures and safety will be carefully monitored. Read more about this study

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Hypertension
What is being tested?: telmisartan/amlodipine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 502 participants
Where: 47 sitesin 5 countries
Study dates: May 2010to May 2011
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 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Ability to provide written informed consent in accordance with Good Clinical Practice and local legislation
Age 18 years or older
Patients with uncontrolled hypertension as defined SBP > 140 mmHg and SBP > 130 mmHg in patients with diabetes or renal impairment or DBP > 90 mmHg and DBP >80 mmHg in patients with diabetes or renal impairment after at least an 6 weeks of stable treatment with antihypertensive medication defined as treatment with the clinically recommended dose of a single RAAS blocking agent (Angiotensin Converting Enzym inhibition, AII Receptor Blocker and Direct Renin Inhibitor) at entering the trial. Renal impairment is defined as a creatinine >133µmol/l (1.5mg/dl) in male patients and a creatinine >124µmol/l (1.3mg/dl) in female patients or a creatinine clearance between 30-60 ml/min

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 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 (e.g., renal artery stenosis or phaeochromocytoma).
Mean in-clinic seated cuff Systolic BP >180 mmHg and SBP >160 mmHg in patients with diabetes or renal impairment or Diastolic BP >110 mmHg and DBP >100 mmHg in patients with diabetes or renal impairment. Renal impairment is defined as a creatinine >133µmol/l (1.5mg/dl) in male patients and a creatinine >124µmol/l (1.3mg/dl) in female patients or a creatinine clearance between 30-60 ml/min.
Renal dysfunction as defined by the following laboratory parameters: Serum creatinine >3.0 mg/dl (or >265 ¿mol/L) and/or known creatinine clearance of <30 ml/min and/or clinical markers of severe renal impairment.
Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post-renal transplant patients or patients with only one kidney.
Clinically relevant hypokalaemia or hyperkalaemia (i.e., <3.5 or >5.5 mEq/L).

Show all 18Show fewer

Uncorrected sodium or volume depletion.
Primary aldosteronism.
Hereditary fructose intolerance.
Congestive heart failure New York Heart Association functional class Congestive Heart Failure III-IV (Refer to Appendix 10.1).
Clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant cardiac arrhythmias as determined by the Investigator.
Biliary obstructive disorders (e.g., cholestasis) or hepatic insufficiency (defined as elevated levels of >2x bilirubin or >2x transaminases values). (Refer to Appendix 10.3)
Patients who have previously experienced symptoms characteristic of angioedema during treatment with ACE inhibitors or angiotensin-II receptor antagonists.
History of drug or alcohol dependency within six months prior to signing the informed consent form.
Any investigational drug therapy within one month of signing the informed consent.
Known hypersensitivity to any component of the trial drugs (telmisartan or amlodipine).
History of non-compliance or inability to comply with prescribed medications or protocol procedures.
Any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of the trial medication.

Trial locations and contacts

47 sites in 5 countries.

Country

City, postcode or hospital

47 sites in 5 countries

Poland12 sites

1235.33.48005 Boehringer Ingelheim Investigational Site
Chorzów
1235.33.48002 Boehringer Ingelheim Investigational Site
Częstochowa
1235.33.48003 Boehringer Ingelheim Investigational Site
Częstochowa
1235.33.48010 Boehringer Ingelheim Investigational Site
Dąbrowa Górnicza
1235.33.48006 Boehringer Ingelheim Investigational Site
Grodzisk Mazowiecki
1235.33.48013 Boehringer Ingelheim Investigational Site
Oświęcim
1235.33.48008 Boehringer Ingelheim Investigational Site
Piotrkow Trybunalski
1235.33.48004 Boehringer Ingelheim Investigational Site
Poznan
1235.33.48001 Boehringer Ingelheim Investigational Site
Tychy
1235.33.48009 Boehringer Ingelheim Investigational Site
Tychy
1235.33.48011 Boehringer Ingelheim Investigational Site
Warsaw
1235.33.48007 Boehringer Ingelheim Investigational Site
Wroclaw

Other trials in Poland

Germany10 sites

1235.33.49010 Boehringer Ingelheim Investigational Site
Berlin
1235.33.49002 Boehringer Ingelheim Investigational Site
Frankfurt
1235.33.49007 Boehringer Ingelheim Investigational Site
Haag
1235.33.49003 Boehringer Ingelheim Investigational Site
Heidelberg
1235.33.49005 Boehringer Ingelheim Investigational Site
Künzing
1235.33.49008 Boehringer Ingelheim Investigational Site
Nuremberg
1235.33.49009 Boehringer Ingelheim Investigational Site
Rednitzhembach
1235.33.49006 Boehringer Ingelheim Investigational Site
Rodgau-Dudenhofen
1235.33.49004 Boehringer Ingelheim Investigational Site
Unterschneidheim
1235.33.49001 Boehringer Ingelheim Investigational Site
Westerkappeln

Other trials in Germany

Netherlands9 sites

1235.33.31007 Boehringer Ingelheim Investigational Site
's-Hertogenbosch
1235.33.31009 Boehringer Ingelheim Investigational Site
Almere Stad
1235.33.31005 Boehringer Ingelheim Investigational Site
Beek en Donk
1235.33.31002 Boehringer Ingelheim Investigational Site
Beerzerveld
1235.33.31008 Boehringer Ingelheim Investigational Site
Ermelo
1235.33.31006 Boehringer Ingelheim Investigational Site
Lichtenvoorde
1235.33.31001 Boehringer Ingelheim Investigational Site
Musselkanaal
1235.33.31004 Boehringer Ingelheim Investigational Site
Nijverdal
1235.33.31003 Boehringer Ingelheim Investigational Site
Wildervank

Other trials in Netherlands

Italy8 sites

1235.33.39009 Boehringer Ingelheim Investigational Site
Arezzo
1235.33.39002 Boehringer Ingelheim Investigational Site
Bologna
1235.33.39004 Boehringer Ingelheim Investigational Site
Ferrara
1235.33.39006 Boehringer Ingelheim Investigational Site
L’Aquila
1235.33.39007 Boehringer Ingelheim Investigational Site
Naples
1235.33.39001 Boehringer Ingelheim Investigational Site
Pisa
1235.33.39008 Boehringer Ingelheim Investigational Site
Roma
1235.33.39005 Boehringer Ingelheim Investigational Site
Stradella (PV)

Other trials in Italy

Mexico8 sites

1235.33.52004 Boehringer Ingelheim Investigational Site
Aguascalientes
1235.33.52002 Boehringer Ingelheim Investigational Site
Durango
1235.33.52001 Boehringer Ingelheim Investigational Site
Guadalajara
1235.33.52003 Boehringer Ingelheim Investigational Site
Guadalajara
1235.33.52007 Boehringer Ingelheim Investigational Site
Guadalajara
1235.33.52006 Boehringer Ingelheim Investigational Site
México
1235.33.52009 Boehringer Ingelheim Investigational Site
México
1235.33.52008 Boehringer Ingelheim Investigational Site
Monterrey

Other trials in Mexico

About this study

Official title: A Prospective, Open-label TElmisartan/AMlodipine Single Pill STudy to Assess the Efficacy in Patients With Essential Hypertension"..."

Read the detailed description

Study Design:

Conditions: Hypertension
Being tested: telmisartan/amlodipine
Medical subject headings: Hypertension

What participants receive

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

telmisartan/amlodipineDrug
start low dose and uptitrate to high dose on the basis of BP goal

Study groups in NCT01134393
Study group	Role	What they receive
telmisartan/amlodipine	Experimental	start low dose and uptitrate to high dose on the basis of blood pressure goal Receives: Drug: telmisartan/amlodipine

What is being measured

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

Percentage of Patients Achieving Blood Pressure (BP) Control After 12 Weeks of Treatment Using In-clinic BP Measurements.
Achieving BP control is defined as SBP<140 mmHg and DBP<90 mmHg.
Measured: 12 weeks

Secondary outcomes (9)

BP Control After 4 and 8 Weeks of Treatment Using In-clinic BP Measurements.
Achieving BP control is defined as SBP<140 mmHg and DBP<90 mmHg.
Measured: 4 and 8 weeks
BP Control (Morning and Evening) After 12 Weeks of Treatment Using Home Blood Pressure Measurement (HBPM).
Achieving BP control with HBPM is defined as SBP<135 mmHg and DBP<85 mmHg.
Measured: Week 12
Change From Baseline Over Time in In-clinic Measured Mean SBP and Mean DBP
Measured: weeks 4, 8 and 12
Change From Baseline Over Time in In-clinic Measured Mean Pulse Rate
Pulse pressure was not analysed for this study instead pulse rate was analysed at weeks 4, 8 and 12.
Measured: weeks 4, 8 and 12
Change From Baseline Over Time in In-clinic Measured Mean Pulse Pressure
Measured: weeks 4, 8 and 12
DBP and SBP Control and Response Rates After 4, 8 and 12 Weeks of Treatment Using In-clinic BP Measurements
DBP control is defined as DBP <90 mmHg or <80 mmHg in patients with diabetes or renal impairment. SBP control is defined as SBP <140 mmHg or <130 mmHg in patients with diabetes or renal impairment. DBP response is defined as DBP <90 mmHg or <80 mmHg in patients with diabetes or renal impairment or a reduction from baseline >=10mmHg. SBP response is defined as SBP<140 mmHg or <130 mmHg in patients with diabetes or renal impairment or a reduction from baseline >=15mmHg.
Measured: weeks 4, 8 and 12
Percentage of Patients in Blood Pressure Categories Over Time
BP optimal: SBP <120 mmHg and DBP <80 mmHg, BP normal: SBP <130 mmHg and DBP <85 mmHg but not optimal, BP high-normal: SBP <140 mmHg and DBP <90 mmHg but not normal. Grade 1 hypertension: SBP <160 mmHg and DBP <100 mmHg but not high-normal, Grade 2 hypertension: SBP <180 mmHg and DBP <110 mmHg but not grade 1, Grade 3 hypertension: SBP >=180 mmHg or DBP >=110 mmHg.
Measured: weeks 4, 8 and 12
DBP and SBP Control and Response Rates Morning and Evening Over Time HBPM Measurements
DBP control: DBP <85 mmHg, SBP control: SBP <135 mmHg, DBP response: DBP <85 mmHg or a reduction from baseline >=10 mmHg, SBP response: SBP <135 mmHg or a reduction from baseline >= 15 mmHg
Measured: weeks 4, 8 and 12
Frequency of Patients Requiring Up-titration to Telmisartan 80mg Plus Amlodipine 10mg Combination (T80/A10) to Achieve Blood Pressure Control Over Time
Measured: weeks 4 and 8

Timeline

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

May 2010May 2011

First posted2 Jun 2010 (estimated)
Study startMay 2010
Primary completionMay 2011

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
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 502 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01134393
Sponsor's protocol ID: 1235.33
Other IDs: 2009-017336-40, 2009
Status last verified: Dec 2013
First submitted: 28 May 2010
Last updated: 15 Jan 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?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 15 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Open-label TElmisartan/AMlodipine Single Pill STudy to Assess the Efficacy in Patients With Essential Hypertension"..."
ClinicalTrials.gov ID: NCT01134393
Acronym / sponsor ID: 1235.33
Conditions: Hypertension
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 502 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: May 2010
Primary completion: May 2011 (actual)
First posted: 2 Jun 2010 (estimated)
Results: Posted 4 Jul 2012

Clinical summary

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

Detailed description

Study Design:

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
telmisartan/amlodipine	Experimental	Drug: telmisartan/amlodipinestart low dose and uptitrate to high dose on the basis of blood pressure goal

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Ability to provide written informed consent in accordance with Good Clinical Practice and local legislation
Age 18 years or older
Patients with uncontrolled hypertension as defined SBP > 140 mmHg and SBP > 130 mmHg in patients with diabetes or renal impairment or DBP > 90 mmHg and DBP >80 mmHg in patients with diabetes or renal impairment after at least an 6 weeks of stable treatment with antihypertensive medication defined as treatment with the clinically recommended dose of a single RAAS blocking agent (Angiotensin Converting Enzym inhibition, AII Receptor Blocker and Direct Renin Inhibitor) at entering the trial. Renal impairment is defined as a creatinine >133µmol/l (1.5mg/dl) in male patients and a creatinine >124µmol/l (1.3mg/dl) in female patients or a creatinine clearance between 30-60 ml/min

Key exclusion criteria (18 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 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 (e.g., renal artery stenosis or phaeochromocytoma).
Mean in-clinic seated cuff Systolic BP >180 mmHg and SBP >160 mmHg in patients with diabetes or renal impairment or Diastolic BP >110 mmHg and DBP >100 mmHg in patients with diabetes or renal impairment. Renal impairment is defined as a creatinine >133µmol/l (1.5mg/dl) in male patients and a creatinine >124µmol/l (1.3mg/dl) in female patients or a creatinine clearance between 30-60 ml/min.
Renal dysfunction as defined by the following laboratory parameters: Serum creatinine >3.0 mg/dl (or >265 ¿mol/L) and/or known creatinine clearance of <30 ml/min and/or clinical markers of severe renal impairment.
Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post-renal transplant patients or patients with only one kidney.

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/amlodipinestart low dose and uptitrate to high dose on the basis of BP goal	Drug	telmisartan/amlodipine

Primary outcome

Percentage of Patients Achieving Blood Pressure (BP) Control After 12 Weeks of Treatment Using In-clinic BP Measurements.
Time frame: 12 weeks
Achieving BP control is defined as SBP<140 mmHg and DBP<90 mmHg.

9 secondary outcomes

BP Control After 4 and 8 Weeks of Treatment Using In-clinic BP Measurements.
Time frame: 4 and 8 weeks
BP Control (Morning and Evening) After 12 Weeks of Treatment Using Home Blood Pressure Measurement (HBPM).
Time frame: Week 12
Change From Baseline Over Time in In-clinic Measured Mean SBP and Mean DBP
Time frame: weeks 4, 8 and 12
Change From Baseline Over Time in In-clinic Measured Mean Pulse Rate
Time frame: weeks 4, 8 and 12
Change From Baseline Over Time in In-clinic Measured Mean Pulse Pressure
Time frame: weeks 4, 8 and 12
DBP and SBP Control and Response Rates After 4, 8 and 12 Weeks of Treatment Using In-clinic BP Measurements
Time frame: weeks 4, 8 and 12
Percentage of Patients in Blood Pressure Categories Over Time
Time frame: weeks 4, 8 and 12
DBP and SBP Control and Response Rates Morning and Evening Over Time HBPM Measurements
Time frame: weeks 4, 8 and 12
Frequency of Patients Requiring Up-titration to Telmisartan 80mg Plus Amlodipine 10mg Combination (T80/A10) to Achieve Blood Pressure Control Over Time
Time frame: weeks 4 and 8

Results and safety

Results posted to the registry on 4 Jul 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
T80/A5	501	449

Primary outcome: Percentage of Patients Achieving Blood Pressure (BP) Control After 12 Weeks of Treatment Using In-clinic BP Measurements.

Time frame: 12 weeks. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	T80/A5 n = 494
Value	67.6 (63.3 to 71.7)

Population analysed: Full Analysis Set (FAS) is defined as all patients who took at least one dose of trial medication, and for whom a baseline measurement and at least one post-baseline efficacy measurement were available. Last observation carried forward (LOCF) will be used.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 weeks: From drug administration until end of treatment plus one day.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
T80/A5	1 of 501 (0.2%)	26 of 501 (5.2%)	Not reported
T80/A10	1 of 232 (0.4%)	41 of 232 (17.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

Related trials for Hypertension

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An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
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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

47 sites in 5 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing telmisartan/amlodipine in people with Hypertension, run by Boehringer Ingelheim at 47 sites in 5 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 3 inclusion and 18 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 15 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 47 sites in Poland, Germany, Netherlands, Italy, Mexico. 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 4 Jul 2012). 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?

Percentage of Patients Achieving Blood Pressure (BP) Control After 12 Weeks of Treatment Using In-clinic BP Measurements. (time frame: 12 weeks). 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 NCT01134393.

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 15 Jan 2014.