HypertensionPhase 3NCT00877929

Telmisartan Fixed Dose Combination vs Amlodipine in Hypertensive Patients With Type 2 Diabetes Mellitus

A Phase 3 study testing Telmisartan 80 and Amlodipine 10 in people with Hypertension, run by Boehringer Ingelheim at 65 sites in 9 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

To demonstrate that the fixed dose combination of telmisartan and amlodipine is more effective in lowering blood pressure. 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 80 and Amlodipine 10
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 706 participants
Where: 65 sitesin 9 countries
Study dates: Feb 2009to May 2010
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

Hypertension defined as a mean in-clinic seated cuff Systolic Blood Pressure >150 mmHg at Visit 3 (Randomisation visit)
Diagnosis of Type 2 diabetes mellitus
=18 years of age at the date of signing the informed consent
Ability to stop current antihypertensive therapy without unacceptable risk to the patient (investigator's discretion)
Ability to provide written informed consent

Who cannot join

Pre-menopausal women (last menstruation <=1 year prior to start of run-in period) who:
are not surgically sterile; and/or
are nursing or pregnant, or
are of child-bearing potential and are NOT practicing acceptable means of birth control or do NOT plan to continue practising an acceptable method throughout the study.
The only acceptable methods of birth control are:
Intrauterine device (IUD);

Show all 32Show fewer

Oral contraceptives (started at least three months prior to start of run-in period)
Implantable or injectable contraceptives and
Estrogen patch
Night shift workers who routinely sleep during the daytime and whose work hours include midnight to 4:00 a.m.
Known or suspected secondary hypertension (e.g., renal artery stenosis, phaeochromocytoma)
Mean seated Systolic Blood Pressure (SBP) =180 mm Hg and/or mean seated Diastolic Blood Pressure (DBP) =110 mm Hg during any visit of the screening and placebo run-in periods
Patients with Type 1 diabetes mellitus
Renal dysfunction as defined by the following laboratory parameters: Serum creatinine >3.0 mg/dL (or >265 µmol /L) or known creatinine clearance <30 mL/min 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
Uncorrected sodium or volume depletion
Primary aldosteronism
Hereditary fructose intolerance
Biliary obstructive disorders (e.g., cholestatis) or hepatic insufficiency
Congestive heart failure New York Heart Academy (NYHA) functional class CHF III-IV (Refer to Appendix 10.3)
Contraindication to a placebo run-in period (e.g., stroke with-in the past six months, myocardial infarction, cardiac surgery, percutaneous transluminal coronary angioplasty, unstable angina or coronary artery bypass graft within the past three months prior to start of run-in period)
Clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant cardiac arrhythmias as determined by the Investigator
Hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, hemodynamically relevant stenosis of the aortic or mitral valve
Patients whose diabetes has not been stable and controlled for at least the past three months as defined by an HbA1C >10%
Patients who have previously experienced symptoms characteristic of angioedema during treatment with Angiotensin Converting Enzyme (ACE) inhibitors or angiotensin-II receptor antagonists
History of drug or alcohol dependency within six months prior to signing the informed consent form
Concomitant administration of any medications known to affect blood pressure, except medications allowed by the protocol
Any investigational drug therapy within one month of signing the informed consent
Known hypersensitivity to any component of the study drugs (telmisartan, amlodipine, or placebo)
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 telmisartan and amlodipine

Trial locations and contacts

65 sites in 9 countries.

Country

City, postcode or hospital

65 sites in 9 countries

United States15 sites

1235.21.908 Boehringer Ingelheim Investigational Site
Carrollton, Texas
1235.21.909 Boehringer Ingelheim Investigational Site
Dallas, Texas
1235.21.911 Boehringer Ingelheim Investigational Site
Ettrick, Virginia
1235.21.913 Boehringer Ingelheim Investigational Site
Fort Lauderdale, Florida
1235.21.915 Boehringer Ingelheim Investigational Site
Hickory, North Carolina
1235.21.910 Boehringer Ingelheim Investigational Site
Hollywood, Florida
1235.21.912 Boehringer Ingelheim Investigational Site
Killeen, Texas
1235.21.901 Boehringer Ingelheim Investigational Site
Long Beach, California
1235.21.902 Boehringer Ingelheim Investigational Site
Oklahoma City, Oklahoma
1235.21.916 Boehringer Ingelheim Investigational Site
Olive Branch, Mississippi
1235.21.903 Boehringer Ingelheim Investigational Site
Pembroke Pines, Florida
1235.21.904 Boehringer Ingelheim Investigational Site
Penndel, Pennsylvania
1235.21.905 Boehringer Ingelheim Investigational Site
Tucker, Georgia
1235.21.907 Boehringer Ingelheim Investigational Site
Tustin, California
1235.21.906 Boehringer Ingelheim Investigational Site
Winston-Salem, North Carolina

Other trials in United States

Netherlands9 sites

1235.21.408 Boehringer Ingelheim Investigational Site
Beek en Donk
1235.21.401 Boehringer Ingelheim Investigational Site
Hoogwoud
1235.21.405 Boehringer Ingelheim Investigational Site
Musselkanaal
1235.21.404 Boehringer Ingelheim Investigational Site
Nijverdal
1235.21.403 Boehringer Ingelheim Investigational Site
Oude Pekela
1235.21.409 Boehringer Ingelheim Investigational Site
Roelofarensveen
1235.21.406 Boehringer Ingelheim Investigational Site
The Hague
1235.21.407 Boehringer Ingelheim Investigational Site
Voerendaal
1235.21.402 Boehringer Ingelheim Investigational Site
Wildervank

Other trials in Netherlands

Slovakia9 sites

1235.21.501 Boehringer Ingelheim Investigational Site
Bratislava
1235.21.502 Boehringer Ingelheim Investigational Site
Bratislava
1235.21.503 Boehringer Ingelheim Investigational Site
Bratislava
1235.21.504 Boehringer Ingelheim Investigational Site
Bratislava
1235.21.507 Boehringer Ingelheim Investigational Site
Dunajská Streda
1235.21.509 Boehringer Ingelheim Investigational Site
Martin
1235.21.505 Boehringer Ingelheim Investigational Site
Nitra
1235.21.506 Boehringer Ingelheim Investigational Site
Nitra
1235.21.508 Boehringer Ingelheim Investigational Site
Rimavská Sobota

Other trials in Slovakia

South Africa7 sites

1235.21.27005 Boehringer Ingelheim Investigational Site
Cape Town
1235.21.27007 Boehringer Ingelheim Investigational Site
Cape Town
1235.21.27004 Boehringer Ingelheim Investigational Site
Durban
1235.21.27006 Boehringer Ingelheim Investigational Site
Johannesburg
1235.21.27002 Boehringer Ingelheim Investigational Site
Krugersdorp
1235.21.27001 Boehringer Ingelheim Investigational Site
Lenasia
1235.21.27003 Boehringer Ingelheim Investigational Site
Pretoria

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Mexico6 sites

1235.21.302 Boehringer Ingelheim Investigational Site
Acapulco
1235.21.304 Boehringer Ingelheim Investigational Site
Aguascalientes
1235.21.301 Boehringer Ingelheim Investigational Site
Guadalajara
1235.21.303 Boehringer Ingelheim Investigational Site
Guadalajara
1235.21.305 Boehringer Ingelheim Investigational Site
Guadalajara
1235.21.306 Boehringer Ingelheim Investigational Site
Guadalajara

Other trials in Mexico

Argentina5 sites

1235.21.102 Boehringer Ingelheim Investigational Site
Capital Federal
1235.21.103 Boehringer Ingelheim Investigational Site
Capital Federal
1235.21.107 Boehringer Ingelheim Investigational Site
Ramos Mejía
1235.21.101 Boehringer Ingelheim Investigational Site
Santa Fe
1235.21.105 Boehringer Ingelheim Investigational Site
Zárate

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South Korea5 sites

1235.21.202 Boehringer Ingelheim Investigational Site
Incheon
1235.21.201 Boehringer Ingelheim Investigational Site
Seoul
1235.21.203 Boehringer Ingelheim Investigational Site
Seoul
1235.21.204 Boehringer Ingelheim Investigational Site
Seoul
1235.21.205 Boehringer Ingelheim Investigational Site
Seoul

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Spain5 sites

1235.21.702 Boehringer Ingelheim Investigational Site
Castellon
1235.21.705 Boehringer Ingelheim Investigational Site
Centelles
1235.21.703 Boehringer Ingelheim Investigational Site
Sant Adrià Del Besós
1235.21.706 Boehringer Ingelheim Investigational Site
Santa Coloma de Gramanet
1235.21.704 Boehringer Ingelheim Investigational Site
Santa Coloma de Gramanet (Barcelona)

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Sweden4 sites

1235.21.801 Boehringer Ingelheim Investigational Site
Gothenburg
1235.21.803 Boehringer Ingelheim Investigational Site
Helsingborg
1235.21.804 Boehringer Ingelheim Investigational Site
Lund
1235.21.802 Boehringer Ingelheim Investigational Site
Västerås

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About this study

Official title: An 8-week Randomised, Double-blind Study to Compare the Fixed-dose Combination of Telmisartan 80 + Amlodipine 10mg Versus Amlodipine 10 mg Monotherapy as First Line Therapy in Type 2 Diabetes Patients With Hypertension.

To demonstrate that the fixed dose combination of telmisartan and amlodipine is more effective in lowering blood pressure.

Conditions: Hypertension
Being tested: Telmisartan 80, Amlodipine 10
Medical subject headings: Hypertension

What participants receive

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

Telmisartan 80Drug
Telmisartan 80 mg
Amlodipine 10Drug
Amlodipine 5 for two weeks, then forced titration to Amlodipine 10
Amlodipine 10Drug
Amlodipine 5 for two weeks, then forced titration to Amlodipine 10

Study groups in NCT00877929
Study group	Role	What they receive
Telmisartan 80 / Amlodipine 10	Experimental	Telmisartan 80 / Amlodipine 5 for two weeks, then forced titration to Telmisartan 80 / Amlodipine 10 Fixed Dose Combination Receives: Drug: Telmisartan 80; Drug: Amlodipine 10
Amlodipine 10	Active comparator	Amlodipine 5 for two weeks, then forced titration to Amlodipine 10 Receives: Drug: Amlodipine 10

What is being measured

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

Change From Baseline in Trough Seated Systolic Blood Pressure to Week 8
Trough blood pressure measurements were the measurements observed at the end of the dosing interval just prior to the next dose of medication.
Measured: Baseline, week 8

Secondary outcomes (40)

Change From Baseline in Trough Seated Systolic Blood Pressure to Week 6
Trough blood pressure measurements were the measurements observed at the end of the dosing interval just prior to the next dose of medication.
Measured: Baseline, week 6
Change From Baseline in Trough Seated Systolic Blood Pressure to Week 4
Trough blood pressure measurements were the measurements observed at the end of the dosing interval just prior to the next dose of medication.
Measured: Baseline, week 4
Change From Baseline in Trough Seated Systolic Blood Pressure to Week 2
Trough blood pressure measurements were the measurements observed at the end of the dosing interval just prior to the next dose of medication.
Measured: Baseline, week 2
Change From Baseline in Trough Seated Systolic Blood Pressure to Week 1
Trough blood pressure measurements were the measurements observed at the end of the dosing interval just prior to the next dose of medication.
Measured: Baseline, week 1
Blood Pressure (BP) Control (SBP<140 mmHg, DBP<90 mmHg) at Eight Weeks
Mean seated SBP<140 mmHg and mean seated DBP<90 mmHg
Measured: Baseline, week 8
BP Control (SBP<140 mmHg, DBP<90 mmHg) at Six Weeks
Mean seated SBP<140 mmHg and mean seated DBP<90 mmHg
Measured: Baseline, week 6
BP Control (SBP<140 mmHg, DBP<90 mmHg) at Four Weeks
Mean seated SBP<140 mmHg and mean seated DBP<90 mmHg
Measured: Baseline, week 4
BP Control (SBP<140 mmHg, DBP<90 mmHg) at Two Weeks
Mean seated SBP<140 mmHg and mean seated DBP<90 mmHg
Measured: Baseline, week 2
BP Control (SBP<140 mmHg, DBP<90 mmHg) at One Week
Mean seated SBP<140 mmHg and mean seated DBP<90 mmHg
Measured: Baseline, week 1
BP Control (SBP<130 mmHg, DBP<80 mmHg) at Eight Weeks
Mean seated SBP<130 mmHg and mean seated DBP<80 mmHg
Measured: Baseline, week 8
BP Control (SBP<130 mmHg, DBP<80 mmHg) at Six Weeks
Mean seated SBP<130 mmHg and mean seated DBP<80 mmHg
Measured: Baseline, week 6
BP Control (SBP<130 mmHg, DBP<80 mmHg) at Four Weeks
Mean seated SBP<130 mmHg and mean seated DBP<80 mmHg
Measured: Baseline, week 4
BP Control (SBP<130 mmHg, DBP<80 mmHg) at Two Weeks
Mean seated SBP<130 mmHg and mean seated DBP<80 mmHg
Measured: Baseline, week 2
BP Control (SBP<130 mmHg, DBP<80 mmHg) at One Week
Mean seated SBP<130 mmHg and mean seated DBP<80 mmHg
Measured: Baseline, week 1
Systolic Blood Pressure (SBP) Control 140 at Eight Weeks
Mean seated SBP < 140 mmHg
Measured: Baseline, week 8
SBP Control 140 at Six Weeks
Mean seated SBP < 140 mmHg
Measured: Baseline, week 6
SBP Control 140 at Four Weeks
Mean seated SBP < 140 mmHg
Measured: Baseline, week 4
SBP Control 140 at Two Weeks
Mean seated SBP < 140 mmHg
Measured: Baseline, week 2
SBP Control 140 at One Week
Mean seated SBP < 140 mmHg
Measured: Baseline, week 1
SBP Control 130 at Eight Weeks
Mean seated SBP < 130 mmHg
Measured: Baseline, week 8
SBP Control 130 at Six Weeks
Mean seated SBP < 130 mmHg
Measured: Baseline, week 6
SBP Control 130 at Four Weeks
Mean seated SBP < 130 mmHg
Measured: Baseline, week 4
SBP Control 130 at Two Weeks
Mean seated SBP < 130 mmHg
Measured: Baseline, week 2
SBP Control 130 at One Week
Mean seated SBP < 130 mmHg
Measured: Baseline, week 1
SBP Response 140 at Eight Weeks
SBP < 140 mmHg or a reduction >=10 mmHg
Measured: Baseline, week 8
SBP Response 140 at Six Weeks
SBP <140 mmHg or a reduction >=10 mmHg
Measured: Baseline, week 6
SBP Response 140 at Four Weeks
SBP <140 mmHg or a reduction >=10 mmHg
Measured: Baseline, week 4
SBP Response 140 at Two Weeks
SBP <140 mmHg or a reduction >=10 mmHg
Measured: Baseline, week 2
SBP Response 140 at One Week
SBP <140 mmHg or a reduction >=10 mmHg
Measured: Baseline, week 1
SBP Response 130 at Eight Weeks
SBP <130 mmHg or a reduction >=10 mmHg
Measured: Baseline, week 8
SBP Response 130 at Six Weeks
SBP <130 mmHg or a reduction >=10 mmHg
Measured: Baseline, week 6
SBP Response 130 at Four Weeks
SBP <130 mmHg or a reduction >=10 mmHg
Measured: Baseline, week 4
SBP Response 130 at Two Weeks
SBP <130 mmHg or a reduction >=10 mmHg
Measured: Baseline, week 2
SBP Response 130 at One Week
SBP <130 mmHg or a reduction >=10 mmHg
Measured: Baseline, week 1
DBP Response at Eight Weeks
Mean seated DBP<80 mmHg or a reduction of <=10 mmHg
Measured: Week 8
DBP Response at Six Weeks
Mean seated DBP<80 mmHg or a reduction of <=10 mmHg
Measured: week 6
DBP Response at Week Four
Mean seated DBP <80 mmHg or a reduction of >=10 mmHg
Measured: Week 4
DBP Response at Week Two
Mean seated DBP <80 mmHg or a reduction of >=10 mmHg
Measured: Week 2
DBP Response at Week One
Mean seated DBP <80 mmHg or a reduction of >=10 mmHg
Measured: Week 1
Change From Baseline in Urine Albumin:Creatinine Ratio (UACR)
Change from baseline in UACR (measured in spot urine) after eight weeks of treatment
Measured: 8 weeks

Timeline

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

Feb 2009May 2010

First posted8 Apr 2009 (estimated)
Study startFeb 2009
Primary completionMay 2010

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: Randomised
Intervention model: Parallel groups
Masking: Double blind
Enrolment: 706 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00877929
Sponsor's protocol ID: 1235.21
Other IDs: 2008-000874-19, 2008
Status last verified: Feb 2014
First submitted: 6 Feb 2009
Last updated: 12 Mar 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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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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All Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An 8-week Randomised, Double-blind Study to Compare the Fixed-dose Combination of Telmisartan 80 + Amlodipine 10mg Versus Amlodipine 10 mg Monotherapy as First Line Therapy in Type 2 Diabetes Patients With Hypertension.
ClinicalTrials.gov ID: NCT00877929
Acronym / sponsor ID: 1235.21
Conditions: Hypertension
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 706 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Feb 2009
Primary completion: May 2010 (actual)
First posted: 8 Apr 2009 (estimated)
Results: Posted 7 Jun 2011

Clinical summary

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

To demonstrate that the fixed dose combination of telmisartan and amlodipine is more effective in lowering blood pressure.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Number of arms: 2

Arm	Type	Receives
Telmisartan 80 / Amlodipine 10	Experimental	Drug: Telmisartan 80, Drug: Amlodipine 10Telmisartan 80 / Amlodipine 5 for two weeks, then forced titration to Telmisartan 80 / Amlodipine 10 Fixed Dose Combination
Amlodipine 10	Active comparator	Drug: Amlodipine 10Amlodipine 5 for two weeks, then forced titration to Amlodipine 10

Who may qualify

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

Key inclusion criteria (5 listed)

Hypertension defined as a mean in-clinic seated cuff Systolic Blood Pressure >150 mmHg at Visit 3 (Randomisation visit)
Diagnosis of Type 2 diabetes mellitus
=18 years of age at the date of signing the informed consent
Ability to stop current antihypertensive therapy without unacceptable risk to the patient (investigator's discretion)
Ability to provide written informed consent

Key exclusion criteria (32 listed)

Pre-menopausal women (last menstruation <=1 year prior to start of run-in period) who:
Night shift workers who routinely sleep during the daytime and whose work hours include midnight to 4:00 a.m.
Known or suspected secondary hypertension (e.g., renal artery stenosis, phaeochromocytoma)
Mean seated Systolic Blood Pressure (SBP) =180 mm Hg and/or mean seated Diastolic Blood Pressure (DBP) =110 mm Hg during any visit of the screening and placebo run-in periods
Patients with Type 1 diabetes mellitus

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 80Telmisartan 80 mg	Drug	Telmisartan 80 / Amlodipine 10
Amlodipine 10Amlodipine 5 for two weeks, then forced titration to Amlodipine 10	Drug	Telmisartan 80 / Amlodipine 10
Amlodipine 10Amlodipine 5 for two weeks, then forced titration to Amlodipine 10	Drug	Amlodipine 10

Primary outcome

Change From Baseline in Trough Seated Systolic Blood Pressure to Week 8
Time frame: Baseline, week 8
Trough blood pressure measurements were the measurements observed at the end of the dosing interval just prior to the next dose of medication.

40 secondary outcomes

Change From Baseline in Trough Seated Systolic Blood Pressure to Week 6
Time frame: Baseline, week 6
Change From Baseline in Trough Seated Systolic Blood Pressure to Week 4
Time frame: Baseline, week 4
Change From Baseline in Trough Seated Systolic Blood Pressure to Week 2
Time frame: Baseline, week 2
Change From Baseline in Trough Seated Systolic Blood Pressure to Week 1
Time frame: Baseline, week 1
Blood Pressure (BP) Control (SBP<140 mmHg, DBP<90 mmHg) at Eight Weeks
Time frame: Baseline, week 8
BP Control (SBP<140 mmHg, DBP<90 mmHg) at Six Weeks
Time frame: Baseline, week 6
BP Control (SBP<140 mmHg, DBP<90 mmHg) at Four Weeks
Time frame: Baseline, week 4
BP Control (SBP<140 mmHg, DBP<90 mmHg) at Two Weeks
Time frame: Baseline, week 2
BP Control (SBP<140 mmHg, DBP<90 mmHg) at One Week
Time frame: Baseline, week 1
BP Control (SBP<130 mmHg, DBP<80 mmHg) at Eight Weeks
Time frame: Baseline, week 8
BP Control (SBP<130 mmHg, DBP<80 mmHg) at Six Weeks
Time frame: Baseline, week 6
BP Control (SBP<130 mmHg, DBP<80 mmHg) at Four Weeks
Time frame: Baseline, week 4
BP Control (SBP<130 mmHg, DBP<80 mmHg) at Two Weeks
Time frame: Baseline, week 2
BP Control (SBP<130 mmHg, DBP<80 mmHg) at One Week
Time frame: Baseline, week 1
Systolic Blood Pressure (SBP) Control 140 at Eight Weeks
Time frame: Baseline, week 8
SBP Control 140 at Six Weeks
Time frame: Baseline, week 6
SBP Control 140 at Four Weeks
Time frame: Baseline, week 4
SBP Control 140 at Two Weeks
Time frame: Baseline, week 2
SBP Control 140 at One Week
Time frame: Baseline, week 1
SBP Control 130 at Eight Weeks
Time frame: Baseline, week 8
SBP Control 130 at Six Weeks
Time frame: Baseline, week 6
SBP Control 130 at Four Weeks
Time frame: Baseline, week 4
SBP Control 130 at Two Weeks
Time frame: Baseline, week 2
SBP Control 130 at One Week
Time frame: Baseline, week 1
SBP Response 140 at Eight Weeks
Time frame: Baseline, week 8
SBP Response 140 at Six Weeks
Time frame: Baseline, week 6
SBP Response 140 at Four Weeks
Time frame: Baseline, week 4
SBP Response 140 at Two Weeks
Time frame: Baseline, week 2
SBP Response 140 at One Week
Time frame: Baseline, week 1
SBP Response 130 at Eight Weeks
Time frame: Baseline, week 8
SBP Response 130 at Six Weeks
Time frame: Baseline, week 6
SBP Response 130 at Four Weeks
Time frame: Baseline, week 4
SBP Response 130 at Two Weeks
Time frame: Baseline, week 2
SBP Response 130 at One Week
Time frame: Baseline, week 1
DBP Response at Eight Weeks
Time frame: Week 8
DBP Response at Six Weeks
Time frame: week 6
DBP Response at Week Four
Time frame: Week 4
DBP Response at Week Two
Time frame: Week 2
DBP Response at Week One
Time frame: Week 1
Change From Baseline in Urine Albumin:Creatinine Ratio (UACR)
Time frame: 8 weeks

Results and safety

Results posted to the registry on 7 Jun 2011, 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 80 mg + Amlodipine 10 mg	352	332
Amlodipine 10 mg	354	319

Primary outcome: Change From Baseline in Trough Seated Systolic Blood Pressure to Week 8

Time frame: Baseline, week 8. Least squares mean (Standard Error). Unit: mmHg

Measure	Telmisartan 80 mg + Amlodipine 10 mg n = 320	Amlodipine 10 mg n = 311
Value	-29.0 (0.66)	-22.9 (0.67)

Telmisartan 80 mg + Amlodipine 10 mg vs Amlodipine 10 mg: Mean Difference (Final Values): -6.1 (95% CI -7.9 to -4.2), p = 0.0001, ANCOVA

Population analysed: Treated Set includes all randomized participants who took at least one dose of treatment

40 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Telmisartan 80 mg + Amlodipine 10 mg	3 of 352 (0.9%)	62 of 352 (17.6%)	Not reported
Amlodipine 10 mg	4 of 354 (1.1%)	71 of 354 (20.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 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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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

65 sites in 9 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Telmisartan 80 and Amlodipine 10 in people with Hypertension, run by Boehringer Ingelheim at 65 sites in 9 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 32 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 12 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 65 sites in United States, Netherlands, Slovakia, South Africa, Mexico and 4 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 7 Jun 2011). 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 Systolic Blood Pressure to Week 8 (time frame: Baseline, week 8). 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 NCT00877929.

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 12 Mar 2014.