HypertensionPhase 3NCT00550953

Filtered Trial for Telmisartan 40mg Non-responder

A Phase 3 study testing telmisartan+amlodipine and telmisartan in people with Hypertension, run by Boehringer Ingelheim at 5 sites in Japan.

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 purpose of this study is to: Demonstrate that a fixed-dose combination of telmisartan 40 mg plus amlodipine 5 mg is superior to telmisartan 40 mg alone in patients with essential hypertension and inadequately controlled with telmisartan 40 mg monotherapy. Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Hypertension
What is being tested?: telmisartan+amlodipine and telmisartan
How many people: 314 participants
Where: 5 sitesJapan
Study dates: Oct 2007to Jul 2008
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Essential hypertensive patients who satisfying non-responder criteria
Male or Female
Age 20 years or older
Outpatient

Who cannot join

Taking four or more anti-hypertensive medications
Secondary hypertension
Mean seated diastolic blood pressure (DBP) > 114 mmHg and/or mean seated systolic blood pressure (SBP) > 200 mmHg at Visit 1, 2, 3, or 4, or mean seated DBP < 90 mmHg at Visit 3.
Sustained ventricular tachycardia or other clinically relevant cardiac arrhythmias
Congestive heart failure patients with the New York Heart Association (NYHA) functional class III-IV
History of myocardial infarction or cardiac surgery within last 6 months

Show all 29Show fewer

History of coronary artery bypass graft or percutaneous coronary intervention (PCI) within last 3 months
History of unstable angina within last 3 months
Hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically relevant stenosis of aortic or mitral valve
History of stroke or transient ischemic attack within last 6 months
History of sudden exacerbation of renal function with angiotensin II receptor blockers (ARBs) or angiotensin converting enzyme (ACE) inhibitors, or patients with post-renal transplant or post-nephrectomy
Experienced characteristic symptoms of angioedema during treatment with ARBs or ACE inhibitors
Known hypersensitivity to any component of the investigational drug , or a known hypersensitivity to dihydropyridine -derived drugs
Hepatic and/or renal dysfunction
Diagnosed biliary atresia or cholestasis
Hyperkalemia
Dehydration
Sodium deficiency
Chronic administration of high doses of acidic nonsteroidal anti-inflammatory drugs (NSAIDs)
Patients who cannot change to the restricted administration and dosage during study period
Pre-menopausal women who meet any one of the following 1 - 3:
Pregnant or possibly pregnant (1)
Nursing (2)
Desire to become pregnant during study period (3)
Drug or alcohol dependency
Complication of malignant tumour or a disease requiring immunosuppressants
Compliance of < 80% or > 120% during the run-in period
Receiving any investigational therapy within 3 months
Judged to be inappropriate by the investigator or the sub-investigator

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

Japan5 sites

1235.14.002 Boehringer Ingelheim Investigational Site
Chofu, Tokyo
1235.14.003 Boehringer Ingelheim Investigational Site
Musashino, Tokyo
1235.14.005 Boehringer Ingelheim Investigational Site
Nishi-ku, Hiroshima, Hiroshima
1235.14.004 Boehringer Ingelheim Investigational Site
Osaka, Osaka
1235.14.001 Boehringer Ingelheim Investigational Site
Shinjuku-ku, Tokyo

Other trials in Japan

About this study

The primary purpose of this study is to:

Demonstrate that a fixed-dose combination of telmisartan 40 mg plus amlodipine 5 mg is superior to telmisartan 40 mg alone in patients with essential hypertension and inadequately controlled with telmisartan 40 mg monotherapy.

Conditions: Hypertension
Being tested: telmisartan+amlodipine, telmisartan
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
telmisartanDrug

What is being measured

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

Decrease in Seated Diastolic Blood Pressure From Baseline to 8 Weeks
The mean of the change value was least square mean which was calculated by analysis of covariance with factor treatment and center, and covariate baseline.
Measured: Baseline and 8 Weeks

Secondary outcomes (7)

Decrease in Seated Systolic Blood Pressure From Baseline to 8 Weeks
The mean of the change value was least square mean which was calculated by analysis of covariance with factor treatment and center, and covariate baseline.
Measured: Baseline and 8 weeks
Percentage of Patients With Seated Trough Diastolic Blood Pressure Less Than 90 mmHg at 8 Weeks (0 Percent at Baseline)
Seated trough diastolic blood pressure defined as blood pressure in a sitting position no later than 24 hours after the last intake
Measured: 8 weeks
Percentage of Patients With Seated Trough Systolic Blood Pressure Less Than 140 mmHg at 8 Weeks (0 Percent at Baseline)
Seated trough systolic blood pressure defined as blood pressure in a sitting position no later than 24 hours after the last intake
Measured: 8 weeks
Percentage of Patients Who Achieved an Adequate Response in Seated Trough Diastolic Blood Pressure at 8 Weeks (0 Percent at Baseline)
Adequate response defined that seated trough diastolic blood pressure was <90 mmHg or decreased from reference baseline by >=10 mmHg at 8 weeks
Measured: 8 weeks
Percentage of Patients Who Achieved an Adequate Response in Seated Trough Systolic Blood Pressure at 8 Weeks (0 Percent at Baseline)
Adequate response defined that seated trough systolic blood pressure was <140 mmHg or decreased from reference baseline by >=20 mmHg at 8 weeks (0 percent at baseline)
Measured: 8 weeks
Percentage of Patients With Optimal, Normal or High Normal Blood Pressure at 8 Weeks (0 Percent at Baseline)
Optimal, normal, high normal blood pressure were defined as follows:
- Optimal: Systolic blood pressure (SBP) < 120 mmHg and diastolic blood pressure (DBP) < 80 mmHg
- Normal: SBP >= 120 mmHg or DBP >= 80 mmHg and SBP < 130 mmHg and DBP < 85 mmHg
- High normal: SBP >= 130 mmHg or DBP >= 85 mmHg and SBP < 140 mmHg and DBP < 90 mmHg
Measured: 8 weeks
Clinically Relevant Abnormalities for Changes in Blood Pressure and Pulse Rate Due to Position Change, Seated Pulse Rate, Laboratory Parameters and ECG
Clinical relevant abnormalities for changes in blood pressure and pulse rate due to position change, seated pulse rate, laboratory parameters and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.
Measured: First administration of randomised treatment to 24 hours post last dose of randomised treatment

Timeline

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

Oct 2007Jul 2008

First posted30 Oct 2007 (estimated)
Study startOct 2007
Primary completionJul 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HypertensionStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

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

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Intervention model: Parallel groups
Enrolment: 314 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00550953
Sponsor's protocol ID: 1235.14
Status last verified: Dec 2013
First submitted: 26 Oct 2007
Last updated: 30 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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All Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Filtered Trial for Telmisartan 40mg Non-responder
ClinicalTrials.gov ID: NCT00550953
Acronym / sponsor ID: 1235.14
Conditions: Hypertension
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 314 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Oct 2007
Primary completion: Jul 2008 (actual)
First posted: 30 Oct 2007 (estimated)
Results: Posted 2 Feb 2010

Clinical summary

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

The primary purpose of this study is to:

Study design

Primary purpose: Treatment
Intervention model: Parallel groups

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Essential hypertensive patients who satisfying non-responder criteria
Male or Female
Age 20 years or older
Outpatient

Key exclusion criteria (29 listed)

Taking four or more anti-hypertensive medications
Secondary hypertension
Mean seated diastolic blood pressure (DBP) > 114 mmHg and/or mean seated systolic blood pressure (SBP) > 200 mmHg at Visit 1, 2, 3, or 4, or mean seated DBP < 90 mmHg at Visit 3.
Sustained ventricular tachycardia or other clinically relevant cardiac arrhythmias
Congestive heart failure patients with the New York Heart Association (NYHA) functional class III-IV

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+amlodipine	Drug	–
telmisartan	Drug	–

Primary outcome

Decrease in Seated Diastolic Blood Pressure From Baseline to 8 Weeks
Time frame: Baseline and 8 Weeks
The mean of the change value was least square mean which was calculated by analysis of covariance with factor treatment and center, and covariate baseline.

7 secondary outcomes

Decrease in Seated Systolic Blood Pressure From Baseline to 8 Weeks
Time frame: Baseline and 8 weeks
Percentage of Patients With Seated Trough Diastolic Blood Pressure Less Than 90 mmHg at 8 Weeks (0 Percent at Baseline)
Time frame: 8 weeks
Percentage of Patients With Seated Trough Systolic Blood Pressure Less Than 140 mmHg at 8 Weeks (0 Percent at Baseline)
Time frame: 8 weeks
Percentage of Patients Who Achieved an Adequate Response in Seated Trough Diastolic Blood Pressure at 8 Weeks (0 Percent at Baseline)
Time frame: 8 weeks
Percentage of Patients Who Achieved an Adequate Response in Seated Trough Systolic Blood Pressure at 8 Weeks (0 Percent at Baseline)
Time frame: 8 weeks
Percentage of Patients With Optimal, Normal or High Normal Blood Pressure at 8 Weeks (0 Percent at Baseline)
Time frame: 8 weeks
Clinically Relevant Abnormalities for Changes in Blood Pressure and Pulse Rate Due to Position Change, Seated Pulse Rate, Laboratory Parameters and ECG
Time frame: First administration of randomised treatment to 24 hours post last dose of randomised treatment

Results and safety

Results posted to the registry on 2 Feb 2010, 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 40 mg Plus Amlodipine 5 mg Fixed-dose Combination	156	150
Telmisartan 40 mg Monotherapy	158	152

Primary outcome: Decrease in Seated Diastolic Blood Pressure From Baseline to 8 Weeks

Time frame: Baseline and 8 Weeks. Mean (Standard Error). Unit: mmHg

Measure	Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination n = 153	Telmisartan 40 mg Monotherapy n = 158
Value	13.49 (0.63)	5.47 (0.62)

Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination vs Telmisartan 40 mg Monotherapy: Mean Difference (Final Values): 8.02 (95% CI 6.41 to 9.63), p <0.0001, ANCOVA

Population analysed: Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after the start of the double-blind maintenance period on final dose.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: From drug administration until 24 hours after last drug administration. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination	1 of 156 (0.6%)	19 of 156 (12.2%)	Not reported
Telmisartan 40 mg Monotherapy	0 of 158 (0%)	16 of 158 (10.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 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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Not yet recruiting
Multimodal AI-Driven Out-of-Hospital Management for Hypertension and Cardiometabolic Risk
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Active, not recruiting
Optimizing Prescribing Decisions for Hospitalized Older Adults With Chronic Conditions
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Enrolling by invitationObservational study
WSACS 2026 Delphi Consensus on the Practical Management of Intra-abdominal Hypertension and Abdominal Compartment Syndrome
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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

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing telmisartan+amlodipine and telmisartan in people with Hypertension, run by Boehringer Ingelheim at 5 sites in Japan.

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 4 inclusion and 29 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 30 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 5 sites in Japan. 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 2 Feb 2010). 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?

Decrease in Seated Diastolic Blood Pressure From Baseline to 8 Weeks (time frame: Baseline and 8 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 NCT00550953.

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 30 Jan 2014.