HypertensionPhase 3NCT00558064

Filtered Trial for Amlodipine Non-responder

A Phase 3 study testing telmisartan+amlodipine and amlodipine in people with Hypertension, run by Boehringer Ingelheim at 41 sites in Japan.

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 a fixed-dose combination of telmisartan 40 mg plus amlodipine 5 mg is superior to amlodipine 5 mg alone in patients with essential hypertension and inadequately controlled with amlodipine 5 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 amlodipine
How many people: 531 participants
Where: 41 sitesJapan
Study dates: Oct 2007to Sep 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 satisfying all of the following criteria;
Male or Female
Age > 20 years
Outpatient
Patients who are able to stop current anti-hypertensive therapy at Visit 1 if taking any anti-hypertensive medications
Patients with an ability to provide written informed consent in accordance with the related laws and guidelines such as Good Clinical Practice (GCP) and the Pharmaceutical Affairs Law.

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

41 sites in 1 country.

City, postcode or hospital

41 sites in 1 country

Japan41 sites

1235.13.037 Boehringer Ingelheim Investigational Site
Azumino, Nagano
1235.13.023 Boehringer Ingelheim Investigational Site
Higashiosaka, Osaka
1235.13.021 Boehringer Ingelheim Investigational Site
Itabashi-ku, Tokyo
1235.13.014 Boehringer Ingelheim Investigational Site
Kashihara, Osaka
1235.13.038 Boehringer Ingelheim Investigational Site
Kitaazumi-gun, Nagano
1235.13.009 Boehringer Ingelheim Investigational Site
Kiyose, Tokyo
1235.13.041 Boehringer Ingelheim Investigational Site
Kobe, Hyogo
1235.13.035 Boehringer Ingelheim Investigational Site
Komoro, Nagano
1235.13.003 Boehringer Ingelheim Investigational Site
Koriyama, Fukushima
1235.13.004 Boehringer Ingelheim Investigational Site
Koriyama, Fukushima
1235.13.027 Boehringer Ingelheim Investigational Site
Koriyama, Fukushima
1235.13.007 Boehringer Ingelheim Investigational Site
Koshigaya, Saitama,
1235.13.008 Boehringer Ingelheim Investigational Site
Koto-ku, Tokyo
1235.13.005 Boehringer Ingelheim Investigational Site
Matsudo, Chiba
1235.13.026 Boehringer Ingelheim Investigational Site
Mito, Ibaraki
1235.13.013 Boehringer Ingelheim Investigational Site
Nagoya, Aichi
1235.13.016 Boehringer Ingelheim Investigational Site
Okayama, Okayama,
1235.13.040 Boehringer Ingelheim Investigational Site
Osaka, Osaka
1235.13.025 Boehringer Ingelheim Investigational Site
Saitama, Saitama
1235.13.001 Boehringer Ingelheim Investigational Site
Sapporo, Hokkaido
1235.13.024 Boehringer Ingelheim Investigational Site
Sapporo, Hokkaido
1235.13.028 Boehringer Ingelheim Investigational Site
Sapporo, Hokkaido
1235.13.030 Boehringer Ingelheim Investigational Site
Sapporo, Hokkaido
1235.13.031 Boehringer Ingelheim Investigational Site
Sapporo, Hokkaido
1235.13.033 Boehringer Ingelheim Investigational Site
Sapporo, Hokkaido
1235.13.034 Boehringer Ingelheim Investigational Site
Sapporo, Hokkaido
1235.13.002 Boehringer Ingelheim Investigational Site
Sendai, Miyagi
1235.13.018 Boehringer Ingelheim Investigational Site
Sendai, Miyagi
1235.13.019 Boehringer Ingelheim Investigational Site
Sendai, Miyagi
1235.13.036 Boehringer Ingelheim Investigational Site
Shimoina-gun, Nagano
1235.13.042 Boehringer Ingelheim Investigational Site
Shinjuku-ku, Tokyo
1235.13.010 Boehringer Ingelheim Investigational Site
Shinjyuku-ku, Tokyo
1235.13.011 Boehringer Ingelheim Investigational Site
Shinjyuku-ku,Tokyo
1235.13.022 Boehringer Ingelheim Investigational Site
Shizuoka, Shizuoka
1235.13.015 Boehringer Ingelheim Investigational Site
Suita, Osaka,
1235.13.017 Boehringer Ingelheim Investigational Site
Takamatsu, Kagawa
1235.13.029 Boehringer Ingelheim Investigational Site
Takamatsu, Kagawa
1235.13.032 Boehringer Ingelheim Investigational Site
Takamatsu, Kagawa
1235.13.012 Boehringer Ingelheim Investigational Site
Takaoka, Toyama
1235.13.039 Boehringer Ingelheim Investigational Site
Takaoka,Toyama
1235.13.020 Boehringer Ingelheim Investigational Site
Tsuchiura, Ibaraki

Other trials in Japan

About this study

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

What participants receive

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

telmisartan+amlodipineDrug
amlodipineDrug

What is being measured

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

Reduction From Reference Baseline in Mean Seated Diastolic Blood Pressure at Trough (24-hour Post-dosing)
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)

Reduction From Reference Baseline in Mean Seated Systolic Blood Pressure at Trough (24-hour Post-dosing)
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
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
- No: SBP >= 140 mmHg and DPB >= 90 mmHg
Measured: 8 weeks
Clinically Relevant Abnormalities for Blood Chemistry, Pulse Rate, Laboratory Parameters and ECG
Clinical relevant abnormalities for blood chemistry, 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 2007Sep 2008

First posted14 Nov 2007 (estimated)
Study startOct 2007
Primary completionSep 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: 531 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00558064
Sponsor's protocol ID: 1235.13
Status last verified: Dec 2013
First submitted: 29 Oct 2007
Last updated: 8 Jul 2014
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 8 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Filtered Trial for Amlodipine Non-responder
ClinicalTrials.gov ID: NCT00558064
Acronym / sponsor ID: 1235.13
Conditions: Hypertension
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 531 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Oct 2007
Primary completion: Sep 2008 (actual)
First posted: 14 Nov 2007 (estimated)
Results: Posted 1 Feb 2010

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
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 (6 listed)

Essential hypertensive patients satisfying all of the following criteria;
Male or Female
Age > 20 years
Outpatient
Patients who are able to stop current anti-hypertensive therapy at Visit 1 if taking any anti-hypertensive medications

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	–
amlodipine	Drug	–

Primary outcome

Reduction From Reference Baseline in Mean Seated Diastolic Blood Pressure at Trough (24-hour Post-dosing)
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

Reduction From Reference Baseline in Mean Seated Systolic Blood Pressure at Trough (24-hour Post-dosing)
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
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 Blood Chemistry, 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 1 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	269	264
Amlodipine 5 mg Monotherapy	262	257

Primary outcome: Reduction From Reference Baseline in Mean Seated Diastolic Blood Pressure at Trough (24-hour Post-dosing)

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

Measure	Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination n = 263	Amlodipine 5 mg Monotherapy n = 257
Value	9.56 (0.61)	4.45 (0.61)

Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination vs Amlodipine 5 mg Monotherapy: Mean Difference (Final Values): 5.11 (95% CI 3.98 to 6.23), p <0.0001, Mixed Models Analysis

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: First administration of randomised treatment to 24 hours post last dose of randomised treatment. 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 269 (0.4%)	25 of 269 (9.3%)	Not reported
Amlodipine 5 mg Monotherapy	2 of 262 (0.8%)	34 of 262 (13%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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RecruitingObservational study
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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

41 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 amlodipine in people with Hypertension, run by Boehringer Ingelheim at 41 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 6 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 8 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 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 1 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?

Reduction From Reference Baseline in Mean Seated Diastolic Blood Pressure at Trough (24-hour Post-dosing) (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 NCT00558064.

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 8 Jul 2014; AzTrials last refreshed its copy on 4 Nov 2026.