HypertensionPhase 3NCT00860262

Telmisartan and Amlodipine Fixed Dose Combination [FDC] Trial for the Treatment of Severe Hypertension

A Phase 3 study testing amlodipine, telmisartan and telmisartan and amlodipine in people with Hypertension, run by Boehringer Ingelheim at 137 sites in 11 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?: amlodipine, telmisartan and telmisartan and amlodipine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 858 participants
Where: 137 sitesin 11 countries
Study dates: Mar 2009to Dec 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

Ability to provide written informed consent in accordance with Good Clinical Practice and local legislation
Age 18 years or older
Patients with severe hypertension as defined SBP greater than 180 mmHg and DBP greater than 95 mmHg at randomisation
Ability to stop any current antihypertensive therapy without unacceptable risk to the patient (Investigators discretion)
Exclusion criteria Mean in-clinic seated cuff SBP >/= 200 mmHg and/or Diastolic Blood Pressure [DBP] >/= 95 mmHg

Who cannot join

None listed.

Trial locations and contacts

137 sites in 11 countries.

Country

City, postcode or hospital

137 sites in 11 countries

France32 sites

1235.20.101A Boehringer Ingelheim Investigational Site
Albens
1235.20.102F Boehringer Ingelheim Investigational Site
Arles
1235.20.103A Boehringer Ingelheim Investigational Site
Béziers
1235.20.103C Boehringer Ingelheim Investigational Site
Béziers
1235.20.103F Boehringer Ingelheim Investigational Site
Béziers
1235.20.106A Boehringer Ingelheim Investigational Site
Bourg Des Cptes
1235.20.109B Boehringer Ingelheim Investigational Site
Brivé
1235.20.108E Boehringer Ingelheim Investigational Site
Carbonne
1235.20.101D Boehringer Ingelheim Investigational Site
Chambéry
1235.20.103E Boehringer Ingelheim Investigational Site
Cournonterral
1235.20.108C Boehringer Ingelheim Investigational Site
Cugnaux
1235.20.106D Boehringer Ingelheim Investigational Site
Étrelles
1235.20.108F Boehringer Ingelheim Investigational Site
Fenouillet
1235.20.102A Boehringer Ingelheim Investigational Site
Gémenos
1235.20.102C Boehringer Ingelheim Investigational Site
Gémenos
1235.20.101C Boehringer Ingelheim Investigational Site
Grésy-sur-Aix
1235.20.108A Boehringer Ingelheim Investigational Site
Labarthe-sur-Lèze
1235.20.108B Boehringer Ingelheim Investigational Site
Labarthe-sur-Lèze
1235.20.106F Boehringer Ingelheim Investigational Site
Louvigné-de-Bais
1235.20.102E Boehringer Ingelheim Investigational Site
Marseille
1235.20.106B Boehringer Ingelheim Investigational Site
Mordelles
1235.20.107A Boehringer Ingelheim Investigational Site
Orthez
1235.20.107B Boehringer Ingelheim Investigational Site
Orthez
1235.20.107E Boehringer Ingelheim Investigational Site
Orthez
1235.20.107G Boehringer Ingelheim Investigational Site
Orthez
1235.20.109A Boehringer Ingelheim Investigational Site
Rosiers-d'Égletons
1235.20.109F Boehringer Ingelheim Investigational Site
Saint-Aulaire
1235.20.104A Boehringer Ingelheim Investigational Site
Saint-Etienne
1235.20.104D Boehringer Ingelheim Investigational Site
Saint-Etienne
1235.20.107F Boehringer Ingelheim Investigational Site
Salies-de-Béarn
1235.20.105A Boehringer Ingelheim Investigational Site
Toulon
1235.20.105D Boehringer Ingelheim Investigational Site
Toulon

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United States30 sites

1235.20.512 Boehringer Ingelheim Investigational Site
Albuquerque, New Mexico
1235.20.527 Boehringer Ingelheim Investigational Site
Bay City, Michigan
1235.20.528 Boehringer Ingelheim Investigational Site
Blue Ridge, Georgia
1235.20.525 Boehringer Ingelheim Investigational Site
Buena Park, California
1235.20.522 Boehringer Ingelheim Investigational Site
Carrollton, Texas
1235.20.508 Boehringer Ingelheim Investigational Site
DeLand, Florida
1235.20.535 Boehringer Ingelheim Investigational Site
Draper, Utah
1235.20.526 Boehringer Ingelheim Investigational Site
Erie, Pennsylvania
1235.20.506 Boehringer Ingelheim Investigational Site
Hialeah, Florida
1235.20.520 Boehringer Ingelheim Investigational Site
Houston, Texas
1235.20.511 Boehringer Ingelheim Investigational Site
Kettering, Ohio
1235.20.530 Boehringer Ingelheim Investigational Site
Killeen, Texas
1235.20.510 Boehringer Ingelheim Investigational Site
Las Vegas, Nevada
1235.20.503 Boehringer Ingelheim Investigational Site
Long Beach, California
1235.20.507 Boehringer Ingelheim Investigational Site
Long Beach, California
1235.20.501 Boehringer Ingelheim Investigational Site
Madison, Wisconsin
1235.20.533 Boehringer Ingelheim Investigational Site
Magna, Utah
1235.20.534 Boehringer Ingelheim Investigational Site
Medford, Oregon
1235.20.516 Boehringer Ingelheim Investigational Site
North Dartmouth, Massachusetts
1235.20.519 Boehringer Ingelheim Investigational Site
Pembroke Pines, Florida
1235.20.523 Boehringer Ingelheim Investigational Site
Port Orange, Florida
1235.20.517 Boehringer Ingelheim Investigational Site
Providence, Rhode Island
1235.20.529 Boehringer Ingelheim Investigational Site
Roseville, California
1235.20.505 Boehringer Ingelheim Investigational Site
Saratoga Springs, Utah
1235.20.537 Boehringer Ingelheim Investigational Site
Tacoma, Washington
1235.20.509 Boehringer Ingelheim Investigational Site
The Bronx, New York
1235.20.513 Boehringer Ingelheim Investigational Site
Tipton, Pennsylvania
1235.20.515 Boehringer Ingelheim Investigational Site
Tulsa, Oklahoma
1235.20.518 Boehringer Ingelheim Investigational Site
Tustin, California
1235.20.521 Boehringer Ingelheim Investigational Site
Westlake Village, California

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Russia11 sites

1235.20.301 Boehringer Ingelheim Investigational Site
Moscow
1235.20.302 Boehringer Ingelheim Investigational Site
Moscow
1235.20.303 Boehringer Ingelheim Investigational Site
Moscow
1235.20.304 Boehringer Ingelheim Investigational Site
Moscow
1235.20.310 Boehringer Ingelheim Investigational Site
Moscow
1235.20.305 Boehringer Ingelheim Investigational Site
Saint Petersburg
1235.20.306 Boehringer Ingelheim Investigational Site
Saint Petersburg
1235.20.307 Boehringer Ingelheim Investigational Site
Saint Petersburg
1235.20.308 Boehringer Ingelheim Investigational Site
Saint Petersburg
1235.20.309 Boehringer Ingelheim Investigational Site
Saint Petersburg
1235.20.311 Boehringer Ingelheim Investigational Site
Saint Petersburg

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Ukraine11 sites

1235.20.451 Boehringer Ingelheim Investigational Site
Kharkiv
1235.20.458 Boehringer Ingelheim Investigational Site
Kharkiv
1235.20.460 Boehringer Ingelheim Investigational Site
Kharkiv
1235.20.453 Boehringer Ingelheim Investigational Site
Kiev
1235.20.454 Boehringer Ingelheim Investigational Site
Kiev
1235.20.455 Boehringer Ingelheim Investigational Site
Kiev
1235.20.456 Boehringer Ingelheim Investigational Site
Kiev
1235.20.457 Boehringer Ingelheim Investigational Site
Kiev
1235.20.461 Boehringer Ingelheim Investigational Site
Kiev
1235.20.452 Boehringer Ingelheim Investigational Site
Lviv
1235.20.459 Boehringer Ingelheim Investigational Site
Odesa

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Bulgaria9 sites

1235.20.001 Boehringer Ingelheim Investigational Site
Burgas
1235.20.002 Boehringer Ingelheim Investigational Site
Sofia
1235.20.003 Boehringer Ingelheim Investigational Site
Sofia
1235.20.005 Boehringer Ingelheim Investigational Site
Sofia
1235.20.006 Boehringer Ingelheim Investigational Site
Sofia
1235.20.007 Boehringer Ingelheim Investigational Site
Sofia
1235.20.008 Boehringer Ingelheim Investigational Site
Sofia
1235.20.009 Boehringer Ingelheim Investigational Site
Sofia
1235.20.004 Boehringer Ingelheim Investigational Site
Stara Zagora

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Hungary9 sites

1235.20.152 Boehringer Ingelheim Investigational Site
Budapest
1235.20.156 Boehringer Ingelheim Investigational Site
Budapest
1235.20.158 Boehringer Ingelheim Investigational Site
Budapest
1235.20.159 Boehringer Ingelheim Investigational Site
Budapest
1235.20.161 Boehringer Ingelheim Investigational Site
Budapest
1235.20.153 Boehringer Ingelheim Investigational Site
Gyöngyös
1235.20.154 Boehringer Ingelheim Investigational Site
Miskolc
1235.20.157 Boehringer Ingelheim Investigational Site
Miskolc
1235.20.155 Boehringer Ingelheim Investigational Site
Mosonmagyaróvár

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Romania9 sites

1235.20.252 Boehringer Ingelheim Investigational Site
Brăila
1235.20.259 Boehringer Ingelheim Investigational Site
Bucharest
1235.20.262 Boehringer Ingelheim Investigational Site
Bucharest
1235.20.254 Boehringer Ingelheim Investigational Site
Iași
1235.20.261 Boehringer Ingelheim Investigational Site
Oradea
1235.20.256 Boehringer Ingelheim Investigational Site
Sibiu
1235.20.251 Boehringer Ingelheim Investigational Site
Târgu Mureş
1235.20.260 Boehringer Ingelheim Investigational Site
Tg. Mures
1235.20.253 Boehringer Ingelheim Investigational Site
Timișoara

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Czechia8 sites

1235.20.052 Boehringer Ingelheim Investigational Site
Benátky nad Jizerou
1235.20.059 Boehringer Ingelheim Investigational Site
Český Krumlov
1235.20.051 Boehringer Ingelheim Investigational Site
Pilsen
1235.20.053 Boehringer Ingelheim Investigational Site
Prague
1235.20.054 Boehringer Ingelheim Investigational Site
Příbram
1235.20.055 Boehringer Ingelheim Investigational Site
Slaný
1235.20.057 Boehringer Ingelheim Investigational Site
Strakonice
1235.20.058 Boehringer Ingelheim Investigational Site
Tábor

Other trials in Czechia

South Korea7 sites

1235.20.207 Boehringer Ingelheim Investigational Site
Busan
1235.20.206 Boehringer Ingelheim Investigational Site
Junam
1235.20.205 Boehringer Ingelheim Investigational Site
Koyang
1235.20.201 Boehringer Ingelheim Investigational Site
Seoul
1235.20.202 Boehringer Ingelheim Investigational Site
Seoul
1235.20.203 Boehringer Ingelheim Investigational Site
Seoul
1235.20.204 Boehringer Ingelheim Investigational Site
Seoul

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Slovakia6 sites

1235.20.355 Boehringer Ingelheim Investigational Site
Galanta
1235.20.353 Boehringer Ingelheim Investigational Site
Košice
1235.20.352 Boehringer Ingelheim Investigational Site
Považská Bystrica
1235.20.354 Boehringer Ingelheim Investigational Site
Rimavská Sobota
1235.20.356 Boehringer Ingelheim Investigational Site
Trnava
1235.20.351 Boehringer Ingelheim Investigational Site
Vráble

Other trials in Slovakia

Spain5 sites

1235.20.406 Boehringer Ingelheim Investigational Site
Barcelona
1235.20.408 Boehringer Ingelheim Investigational Site
Barcelona
1235.20.402 Boehringer Ingelheim Investigational Site
Granada
1235.20.403 Boehringer Ingelheim Investigational Site
Seville
1235.20.409 Boehringer Ingelheim Investigational Site
Valencia

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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 mg & Amlodipine 10mg Versus Telmisartan 80 mg Monotherapy or Amlodipine 10 mg Monotherapy as First Line Therapy in Patients With Severe Hypertension (Grade 3).

The primary objective of this trial is to demonstrate that following eight weeks of treatment the FDC of telmisartan 80 mg plus amlodipine 10 mg (T80/A10) is superior as first line therapy in reducing mean seated trough cuff Systolic Blood Pressure [SBP] compared to the monotherapies of telmisartan 80 mg (T80) and amlodipine 10 mg (A10) in patients with severe hypertension. A key secondary objective is to identify the duration of treatment required to demonstrate the superiority of the FDC over both of the monotherapies.

Conditions: Hypertension
Being tested: amlodipine, telmisartan, telmisartan and amlodipine
Medical subject headings: Hypertension

What participants receive

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

amlodipineDrug
amlodipine 5mg for the first 2w then force titration to Amlodipine 10mg for remaining 6 w
telmisartanDrug
telmisartan 80mg for the 8w, no titration required
telmisartan and amlodipineDrug
telmisartan 80 and amlodipine 5mg for the first 2 weeks, then force titrated to telmisartan 80mg and amlodipine 10mg for the remaining 6w

Study groups in NCT00860262
Study group	Role	What they receive
telmisartan and amlodipine	Experimental	telmisartan and amlodipine used in combination vs amlodipine or telmisartan Receives: Drug: telmisartan and amlodipine
amlodipine	Active comparator	telmisartan and amlodipine used in combination vs amlodipine or telmisartan Receives: Drug: amlodipine
telmisartan	Active comparator	telmisartan and amlodipine used in combination vs amlodipine or telmisartan Receives: Drug: telmisartan

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 (SBP) at Week 8
Overall mean reduction from a common mean baseline in SBP
Measured: baseline and week 8

Secondary outcomes (34)

Change From Baseline in Trough Seated Systolic Blood Pressure at Week 6
Overall mean reduction from a common mean baseline in SBP
Measured: baseline and week 6
Change From Baseline in Trough Seated Systolic Blood Pressure at Week 4
Overall mean reduction from a common mean baseline in SBP
Measured: baseline and week 4
Change From Baseline in Trough Seated Systolic Blood Pressure at Week 2
Overall mean reduction from a common mean baseline in SBP
Measured: baseline and week 2
Change From Baseline in Trough Seated Systolic Blood Pressure at Week 1
Overall mean reduction from a common mean baseline in SBP
Measured: baseline and week 1
Change From Baseline in Trough Seated Diastolic Blood Pressure (DBP) at Week 8
Overall mean reduction from a common mean baseline in DBP
Measured: baseline and week 8
Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 6
Overall mean reduction from a common mean baseline in DBP
Measured: baseline and week 6
Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 4
Overall mean reduction from a common mean baseline in DBP
Measured: baseline and week 4
Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 2
Overall mean reduction from a common mean baseline in DBP
Measured: baseline and week 2
Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 1
Overall mean reduction from a common mean baseline in DBP
Measured: baseline and week 1
Patients Achieving Diastolic Blood Pressure Control at Week 1
Diastolic Blood Pressure Control is defined as achieving DBP < 90mmHg
Measured: week 1
Patients Achieving Diastolic Blood Pressure Control at Week 2
DBP < 90 mmHg
Measured: week 2
Patients Achieving Blood Pressure Control at Week 1
Blood Pressure Control is defined as achieving SBP< 140 mmHg and DBP < 90mmHg
Measured: week 1
Patients Achieving Blood Pressure Control at Week 2
SBP < 140 mmHg and DBP < 90 mmHg
Measured: week 2
Patients Achieving Diastolic Blood Pressure Response at Week 1
Diastolic Blood Pressure Response is defined as achieving DBP < 90 mmHg or a reduction of >= 10 mmHg
Measured: baseline, week 1
Patients Achieving Diastolic Blood Pressure Response at Week 2
DBP < 90 mmHg or reduction of >= 10 mmHg
Measured: baseline, week 2
Patients Achieving Systolic Blood Pressure Response at Week 1
Systolic Blood Pressure Response Control is defined as achieving SBP < 140 mmHg or a reduction of >= 15 mmHg
Measured: baseline, week 1
Patients Achieving Systolic Blood Pressure Response at Week 2
SBP < 140 mmHg or reduction of >= 15 mmHg
Measured: baseline, week 2
Number of Patients Achieving Various Blood Pressure Response Levels at Week 1
Optimal: SBP<120 and DBP< 80; Normal: 120<=SBP<130 and 80<= DBP<85; High normal: 130<=SBP<140 and 85<=DBP<90; High: SBP>=140 or DBP>=90
Measured: week 1
Number of Patients Achieving Various Blood Pressure Response Levels at Week 2
Optimal: SBP<120 and DBP< 80; Normal: 120<=SBP<130 and 80<= DBP<85; High normal: 130<=SBP<140 and 85<=DBP<90; High: SBP>=140 or DBP>=90
Measured: week 2
Patients Achieving Diastolic Blood Pressure Control at Week 4
DBP < 90 mmHg
Measured: week 4
Patients Achieving Diastolic Blood Pressure Control at Week 6
DBP < 90 mmHg
Measured: week 6
Patients Achieving Diastolic Blood Pressure Control at Week 8
DBP < 90 mmHg
Measured: week 8
Patients Achieving Blood Pressure Control at Week 4
SBP < 140 mmHg and DBP < 90 mmHg
Measured: week 4
Patients Achieving Blood Pressure Control at Week 6
SBP < 140 mmHg and DBP < 90 mmHg
Measured: week 6
Patients Achieving Blood Pressure Control at Week 8
SBP < 140 mmHg and DBP < 90 mmHg
Measured: week 8
Patients Achieving Diastolic Blood Pressure Response at Week 4
DBP < 90 mmHg or reduction of >= 10 mmHg
Measured: baseline, week 4
Patients Achieving Diastolic Blood Pressure Response at Week 6
DBP < 90 mmHg or reduction of >= 10 mmHg
Measured: baseline, week 6
Patients Achieving Diastolic Blood Pressure Response at Week 8
DBP < 90 mmHg or reduction of >= 10 mmHg
Measured: baseline, week 8
Patients Achieving Systolic Blood Pressure Response at Week 4
SBP < 140 mmHg or reduction of >= 15 mmHg
Measured: baseline, week 4
Patients Achieving Systolic Blood Pressure Response at Week 6
SBP < 140 mmHg or reduction of >= 15 mmHg
Measured: baseline, week 6
Patients Achieving Systolic Blood Pressure Response at Week 8
SBP < 140 mmHg or reduction of >= 15 mmHg
Measured: baseline, week 8
Patients Achieving Normal Blood Pressure Response at Week 4
Optimal: SBP<120 and DBP< 80; Normal: 120<=SBP<130 and 80<= DBP<85; High normal: 130<=SBP<140 and 85<=DBP<90; High: SBP>=140 or DBP>=90
Measured: week 4
Patients Achieving Normal Blood Pressure Response at Week 6
Optimal: SBP<120 and DBP< 80; Normal: 120<=SBP<130 and 80<= DBP<85; High normal: 130<=SBP<140 and 85<=DBP<90; High: SBP>=140 or DBP>=90
Measured: week 6
Patients Achieving Normal Blood Pressure Response at Week 8
Optimal: SBP<120 and DBP< 80; Normal: 120<=SBP<130 and 80<= DBP<85; High normal: 130<=SBP<140 and 85<=DBP<90; High: SBP>=140 or DBP>=90
Measured: week 8

Timeline

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

Mar 2009Dec 2009

First posted12 Mar 2009 (estimated)
Study startMar 2009
Primary completionDec 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.
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: 858 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00860262
Sponsor's protocol ID: 1235.20
Other IDs: 2008-000873-40, 2008
Status last verified: May 2014
First submitted: 11 Mar 2009
Last updated: 20 May 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 20 May 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 mg & Amlodipine 10mg Versus Telmisartan 80 mg Monotherapy or Amlodipine 10 mg Monotherapy as First Line Therapy in Patients With Severe Hypertension (Grade 3).
ClinicalTrials.gov ID: NCT00860262
Acronym / sponsor ID: 1235.20
Conditions: Hypertension
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 858 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Mar 2009
Primary completion: Dec 2009 (actual)
First posted: 12 Mar 2009 (estimated)
Results: Posted 4 Jan 2011

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
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Number of arms: 3

Arm	Type	Receives
telmisartan and amlodipine	Experimental	Drug: telmisartan and amlodipinetelmisartan and amlodipine used in combination vs amlodipine or telmisartan
amlodipine	Active comparator	Drug: amlodipinetelmisartan and amlodipine used in combination vs amlodipine or telmisartan
telmisartan	Active comparator	Drug: telmisartantelmisartan and amlodipine used in combination vs amlodipine or telmisartan

Who may qualify

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

Key inclusion criteria (5 listed)

Ability to provide written informed consent in accordance with Good Clinical Practice and local legislation
Age 18 years or older
Patients with severe hypertension as defined SBP greater than 180 mmHg and DBP greater than 95 mmHg at randomisation
Ability to stop any current antihypertensive therapy without unacceptable risk to the patient (Investigators discretion)
Exclusion criteria Mean in-clinic seated cuff SBP >/= 200 mmHg and/or Diastolic Blood Pressure [DBP] >/= 95 mmHg

Key exclusion criteria (0 listed)

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
amlodipineamlodipine 5mg for the first 2w then force titration to Amlodipine 10mg for remaining 6 w	Drug	amlodipine
telmisartantelmisartan 80mg for the 8w, no titration required	Drug	telmisartan
telmisartan and amlodipinetelmisartan 80 and amlodipine 5mg for the first 2 weeks, then force titrated to telmisartan 80mg and amlodipine 10mg for the remaining 6w	Drug	telmisartan and amlodipine

Primary outcome

Change From Baseline in Trough Seated Systolic Blood Pressure (SBP) at Week 8
Time frame: baseline and week 8
Overall mean reduction from a common mean baseline in SBP

34 secondary outcomes

Change From Baseline in Trough Seated Systolic Blood Pressure at Week 6
Time frame: baseline and week 6
Change From Baseline in Trough Seated Systolic Blood Pressure at Week 4
Time frame: baseline and week 4
Change From Baseline in Trough Seated Systolic Blood Pressure at Week 2
Time frame: baseline and week 2
Change From Baseline in Trough Seated Systolic Blood Pressure at Week 1
Time frame: baseline and week 1
Change From Baseline in Trough Seated Diastolic Blood Pressure (DBP) at Week 8
Time frame: baseline and week 8
Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 6
Time frame: baseline and week 6
Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 4
Time frame: baseline and week 4
Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 2
Time frame: baseline and week 2
Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 1
Time frame: baseline and week 1
Patients Achieving Diastolic Blood Pressure Control at Week 1
Time frame: week 1
Patients Achieving Diastolic Blood Pressure Control at Week 2
Time frame: week 2
Patients Achieving Blood Pressure Control at Week 1
Time frame: week 1
Patients Achieving Blood Pressure Control at Week 2
Time frame: week 2
Patients Achieving Diastolic Blood Pressure Response at Week 1
Time frame: baseline, week 1
Patients Achieving Diastolic Blood Pressure Response at Week 2
Time frame: baseline, week 2
Patients Achieving Systolic Blood Pressure Response at Week 1
Time frame: baseline, week 1
Patients Achieving Systolic Blood Pressure Response at Week 2
Time frame: baseline, week 2
Number of Patients Achieving Various Blood Pressure Response Levels at Week 1
Time frame: week 1
Number of Patients Achieving Various Blood Pressure Response Levels at Week 2
Time frame: week 2
Patients Achieving Diastolic Blood Pressure Control at Week 4
Time frame: week 4
Patients Achieving Diastolic Blood Pressure Control at Week 6
Time frame: week 6
Patients Achieving Diastolic Blood Pressure Control at Week 8
Time frame: week 8
Patients Achieving Blood Pressure Control at Week 4
Time frame: week 4
Patients Achieving Blood Pressure Control at Week 6
Time frame: week 6
Patients Achieving Blood Pressure Control at Week 8
Time frame: week 8
Patients Achieving Diastolic Blood Pressure Response at Week 4
Time frame: baseline, week 4
Patients Achieving Diastolic Blood Pressure Response at Week 6
Time frame: baseline, week 6
Patients Achieving Diastolic Blood Pressure Response at Week 8
Time frame: baseline, week 8
Patients Achieving Systolic Blood Pressure Response at Week 4
Time frame: baseline, week 4
Patients Achieving Systolic Blood Pressure Response at Week 6
Time frame: baseline, week 6
Patients Achieving Systolic Blood Pressure Response at Week 8
Time frame: baseline, week 8
Patients Achieving Normal Blood Pressure Response at Week 4
Time frame: week 4
Patients Achieving Normal Blood Pressure Response at Week 6
Time frame: week 6
Patients Achieving Normal Blood Pressure Response at Week 8
Time frame: week 8

Results and safety

Results posted to the registry on 4 Jan 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
T80+A10	421	401
Telmisartan 80 mg	217	195
Amlodipine 10 mg	220	202

Primary outcome: Change From Baseline in Trough Seated Systolic Blood Pressure (SBP) at Week 8

Time frame: baseline and week 8. Least squares mean (Standard Error). Unit: mmHg (millimeters of mercury)

Measure	T80+A10 n = 379	Telmisartan 80 mg n = 189	Amlodipine 10 mg n = 195
Value	-47.5 (0.69)	-36.9 (0.96)	-43.2 (0.95)

T80+A10 vs Telmisartan 80 mg: Mean Difference (Final Values): -10.6 (95% CI -12.9 to -8.3), p <0.0001, Repeated measures ANCOVA
T80+A10 vs Amlodipine 10 mg: Mean Difference (Final Values): -4.4 (95% CI -6.7 to -2.1), p = 0.0002, Repeated measures ANCOVA

Population analysed: Full analysis set (FAS) included all randomised patients who had at least one seated trough cuff SBP following administration of study drug.

34 secondary outcomes are reported in the full results.

Adverse events

Time frame: First study medication intake, last study medication intake + 6 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
T80+A10	3 of 421 (0.7%)	67 of 421 (15.9%)	Not reported
Telmisartan 80 mg	2 of 217 (0.9%)	25 of 217 (11.5%)	Not reported
Amlodipine 10 mg	2 of 220 (0.9%)	42 of 220 (19.1%)	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.
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

137 sites in 11 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing amlodipine, telmisartan and telmisartan and amlodipine in people with Hypertension, run by Boehringer Ingelheim at 137 sites in 11 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 0 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 137 sites in France, United States, Russia, Ukraine, Bulgaria and 6 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 4 Jan 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 (SBP) at Week 8 (time frame: baseline and 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 NCT00860262.

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.