HypertensionPhase 3NCT01103960

An Eight-week Randomized,Double-blind Study to Evaluate the Efficacy and Safety of Fixed-dose Combinations of T80+A5 Versus A5 Monotherapy in Patients With Hypertension Who Fail to Respond Adequately to Treatment With A5 Monotherapy

A Phase 3 study testing Telmisartan80mg+Amlodipine5mg, amlodipine 5mg and Telmisartan80mg+Amlodipine 5mg in people with Hypertension, run by Boehringer Ingelheim at 16 sites in 3 countries.

Completed

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

Official record

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Trial summary

The primary objectives of this trial is to demonstrate that the fixed-dose combination of telmisartan 80mg plus amlodipine 5mg (T80/A5) is superior to amlodipine 5mg (A5) in reducing seated trough diastolic blood pressure (DBP) at 8 weeks. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hypertension
What is being tested?: Telmisartan80mg+Amlodipine5mg, amlodipine 5mg and Telmisartan80mg+Amlodipine 5mg
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 324 participants
Where: 16 sitesin 3 countries
Study dates: Jul 2010to Aug 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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

diagnosis of essential hypertension
failure to respond adequately to six weeks treatment with amlodipine 5 mg monotherapy
provision of written informed consent

Who cannot join

1. clinical conditions which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of telmisartan and amlodipine for the planned duration of this trial (e.g. populations where labeling of either product recommends against its utilization)

Trial locations and contacts

16 sites in 3 countries.

Country

City, postcode or hospital

16 sites in 3 countries

China12 sites

1235.29.86001 Boehringer Ingelheim Investigational Site
Beijing
1235.29.86004 Boehringer Ingelheim Investigational Site
Beijing
1235.29.86006 Boehringer Ingelheim Investigational Site
Changchun
1235.29.86013 Boehringer Ingelheim Investigational Site
Changsha
1235.29.86014 Boehringer Ingelheim Investigational Site
Guangzhou
1235.29.86012 Boehringer Ingelheim Investigational Site
Hangzhou
1235.29.86002 Boehringer Ingelheim Investigational Site
Shanghai
1235.29.86009 Boehringer Ingelheim Investigational Site
Shanghai
1235.29.86010 Boehringer Ingelheim Investigational Site
Shanghai
1235.29.86011 Boehringer Ingelheim Investigational Site
Shanghai
1235.29.86007 Boehringer Ingelheim Investigational Site
Shenyang
1235.29.86008 Boehringer Ingelheim Investigational Site
Tianjin

Other trials in China

Malaysia2 sites

1235.29.60017 Boehringer Ingelheim Investigational Site
Johor Bahru
1235.29.60016 Boehringer Ingelheim Investigational Site
Kuala Lumpur

Other trials in Malaysia

Philippines2 sites

1235.29.63018 Boehringer Ingelheim Investigational Site
Metro Manila
1235.29.63019 Boehringer Ingelheim Investigational Site
Quezon City

Other trials in Philippines

About this study

Official title: 8 Week Randomised Double-blind Study to Compare the Efficacy and Safety of Telmisartan 80mg+ Amlodipine 5 mg vs. Amlodipine 5mg Monotherapy in Patients With Hypertension Who Fail to Respond Adequately to Treatment With Amlodipine 5mg Monotherapy

Conditions: Hypertension
Being tested: Telmisartan80mg+Amlodipine5mg, amlodipine 5mg, Telmisartan80mg+Amlodipine 5mg
Medical subject headings: Hypertension

What participants receive

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

Telmisartan80mg+Amlodipine5mgDrug
combination therapy
amlodipine 5mgDrug
monotherapy
Telmisartan80mg+Amlodipine 5mgDrug
combination therapy

Study groups in NCT01103960
Study group	Role	What they receive
Telmisartan80mg+Amlodipine5mg	Experimental	combination therapy Receives: Drug: Telmisartan80mg+Amlodipine5mg
amlodipine 5 mg	Active comparator	Monotherapy Receives: Drug: amlodipine 5mg; Drug: Telmisartan80mg+Amlodipine 5mg

What is being measured

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

Change From Baseline in DBP After 8 Weeks of Treatment
Seated trough DBP after 8 weeks or last observation carried forward (LOCF). Analysis will be adjusted for treatment, country, and baseline measurement of endpoint.
Measured: Baseline and 8 weeks
Change From Baseline in DBP After 8 Weeks of Treatment in Chinese Patients
Seated trough DBP after 8 weeks or LOCF in Chinese patients. Analysis will be adjusted for treatment and baseline measurement of endpoint.
Measured: Baseline and 8 weeks

Secondary outcomes (8)

Change From Baseline in SBP After 8 Weeks of Treatment
Seated trough SBP after 8 weeks or LOCF. Analysis will be adjusted for treatment, country, and baseline measurement of endpoint.
Measured: Baseline and 8 weeks
DBP and SBP Control and Response After 8 Weeks of Treatment
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: Baseline and 8 weeks
Number 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: 8 weeks
Change From Baseline in DBP After 4 Weeks of Treatment
Seated trough DBP after 4 weeks.
Measured: Baseline and 4 weeks
Change From Baseline in SBP After 4 Weeks of Treatment
Seated trough SBP after 4 weeks.
Measured: Baseline and 4 weeks
DBP and SBP Control and Response After 4 Weeks of Treatment
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: Baseline and 4 weeks
Number of Patients in Blood Pressure Categories at 4 Weeks
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: 4 weeks
Clinically Relevant Abnormalities for Physical Examination, Pulse Rate, Laboratory Parameters and ECG.
Clinically relevant abnormalities for Physical examination, pulse rate, laboratory parameters and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.
Measured: From drug administration until end of treatment plus one day

Timeline

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

Jul 2010Aug 2011

First posted15 Apr 2010 (estimated)
Study startJul 2010
Primary completionAug 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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HypertensionStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Enrolment: 324 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01103960
Sponsor's protocol ID: 1235.29
Status last verified: Dec 2013
First submitted: 13 Apr 2010
Last updated: 27 Jun 2014
Results posted: Yes, on ClinicalTrials.gov

Publications

Zhu D, Gao P, Holtbruegge W, Huang C. A randomized, double-blind study to evaluate the efficacy and safety of a single-pill combination of telmisartan 80 mg/amlodipine 5 mg versus amlodipine 5 mg in hypertensive Asian patients. J Int Med Res. 2014 Feb;42(1):52-66. doi: 10.1177/0300060513503756. Epub 2014 Jan 3.
PubMed 24391142

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

Official title: 8 Week Randomised Double-blind Study to Compare the Efficacy and Safety of Telmisartan 80mg+ Amlodipine 5 mg vs. Amlodipine 5mg Monotherapy in Patients With Hypertension Who Fail to Respond Adequately to Treatment With Amlodipine 5mg Monotherapy
ClinicalTrials.gov ID: NCT01103960
Acronym / sponsor ID: 1235.29
Conditions: Hypertension
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 324 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Jul 2010
Primary completion: Aug 2011 (actual)
First posted: 15 Apr 2010 (estimated)
Results: Posted 20 Sep 2012

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: 2

Arm	Type	Receives
Telmisartan80mg+Amlodipine5mg	Experimental	Drug: Telmisartan80mg+Amlodipine5mgcombination therapy
amlodipine 5 mg	Active comparator	Drug: amlodipine 5mg, Drug: Telmisartan80mg+Amlodipine 5mgMonotherapy

Who may qualify

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

Key inclusion criteria (3 listed)

diagnosis of essential hypertension
failure to respond adequately to six weeks treatment with amlodipine 5 mg monotherapy
provision of written informed consent

Key exclusion criteria (1 listed)

1. clinical conditions which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of telmisartan and amlodipine for the planned duration of this trial (e.g. populations where labeling of either product recommends against its utilization)

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
Telmisartan80mg+Amlodipine5mgcombination therapy	Drug	Telmisartan80mg+Amlodipine5mg
amlodipine 5mgmonotherapy	Drug	amlodipine 5 mg
Telmisartan80mg+Amlodipine 5mgcombination therapy	Drug	amlodipine 5 mg

Primary outcome

Change From Baseline in DBP After 8 Weeks of Treatment
Time frame: Baseline and 8 weeks
Seated trough DBP after 8 weeks or last observation carried forward (LOCF). Analysis will be adjusted for treatment, country, and baseline measurement of endpoint.
Change From Baseline in DBP After 8 Weeks of Treatment in Chinese Patients
Time frame: Baseline and 8 weeks
Seated trough DBP after 8 weeks or LOCF in Chinese patients. Analysis will be adjusted for treatment and baseline measurement of endpoint.

8 secondary outcomes

Change From Baseline in SBP After 8 Weeks of Treatment
Time frame: Baseline and 8 weeks
DBP and SBP Control and Response After 8 Weeks of Treatment
Time frame: Baseline and 8 weeks
Number of Patients in Blood Pressure Categories Over Time
Time frame: 8 weeks
Change From Baseline in DBP After 4 Weeks of Treatment
Time frame: Baseline and 4 weeks
Change From Baseline in SBP After 4 Weeks of Treatment
Time frame: Baseline and 4 weeks
DBP and SBP Control and Response After 4 Weeks of Treatment
Time frame: Baseline and 4 weeks
Number of Patients in Blood Pressure Categories at 4 Weeks
Time frame: 4 weeks
Clinically Relevant Abnormalities for Physical Examination, Pulse Rate, Laboratory Parameters and ECG.
Time frame: From drug administration until end of treatment plus one day

Results and safety

Results posted to the registry on 20 Sep 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
A5 Alone	164	159
T80/A5	160	158

Primary outcome: Change From Baseline in DBP After 8 Weeks of Treatment

Time frame: Baseline and 8 weeks. Least squares mean (Standard Error). Unit: mmHg

Measure	A5 Alone n = 159	T80/A5 n = 155
Value	-10.19 (0.93)	-12.38 (0.95)

A5 Alone vs T80/A5: Mean Difference (Final Values): 2.1881 (95% CI 0.6082 to 3.7681), p = 0.007, ANCOVA

Population analysed: Full analysis set (FAS) defined as patients randomised, treated, with a baseline endpoint measurement and at least one post-dose endpoint measurement during the double blind (DB) phase.

Primary outcome: Change From Baseline in DBP After 8 Weeks of Treatment in Chinese Patients

Time frame: Baseline and 8 weeks. Least squares mean (Standard Error). Unit: mmHg

Measure	A5 Alone n = 133	T80/A5 n = 129
Value	-8.85 (0.63)	-10.77 (0.64)

A5 Alone vs T80/A5: Mean Difference (Final Values): 1.9195 (95% CI 0.1443 to 3.6947), p = 0.034, ANCOVA

Population analysed: FAS with LOCF and further restricted to the Chinese subgroup

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: 8 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
A5 Alone	0 of 164 (0%)	0 of 164 (0%)	Not reported
T80/A5	0 of 160 (0%)	0 of 160 (0%)	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.
Derived from this study: PubMed 24391142Zhu D, Gao P, Holtbruegge W, Huang C. A randomized, double-blind study to evaluate the efficacy and safety of a single-pill combination of telmisartan 80 mg/amlodipine 5 mg versus amlodipine 5 mg in hypertensive Asian patients. J Int Med Res. 2014 Feb;42(1):52-66. doi: 10.1177/0300060513503756. Epub 2014 Jan 3.

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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

16 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Telmisartan80mg+Amlodipine5mg, amlodipine 5mg and Telmisartan80mg+Amlodipine 5mg in people with Hypertension, run by Boehringer Ingelheim at 16 sites in 3 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 1 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 16 sites in China, Malaysia, Philippines. 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 20 Sep 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?

Change From Baseline in DBP After 8 Weeks of Treatment (time frame: Baseline and 8 weeks). 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 NCT01103960, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2014.