HypertensionPhase 3NCT00618774

An Open-label, Long-term Study of Telmisartan Plus Amlodipine Fixed-dose Combination

A Phase 3 study testing telmisartan40/amlodipine5 and telmisartan80/amlodipine5 in people with Hypertension, run by Boehringer Ingelheim at 7 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

To assess the long term safety and efficacy of telmisartan plus amlodipine FDC in patients with essential hypertension who failed to control their BP with either 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?: telmisartan40/amlodipine5 and telmisartan80/amlodipine5
How many people: 259 participants
Where: 7 sitesJapan
Study dates: Jan 2008to Oct 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 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients with essential hypertension
Outpatient

Who cannot join

Patients whose SBP >=180 mmHg or DBP >=110 mmHg at the end of treatment visit of the double-blind treatment period in the "non-responder trials"
Patients who have met any of the exclusion criteria defined in the "non-responder trials"

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

Japan7 sites

1235.16.004 Boehringer Ingelheim Investigational Site
Chofu, Tokyo
1235.16.006 Boehringer Ingelheim Investigational Site
Nishi-ku, Hiroshima, Hiroshima
1235.16.005 Boehringer Ingelheim Investigational Site
Osaka, Osaka
1235.16.007 Boehringer Ingelheim Investigational Site
Osaka, Osaka
1235.16.003 Boehringer Ingelheim Investigational Site
Shinjuku-ku, Tokyo
1235.16.001 Boehringer Ingelheim Investigational Site
Shinjyuku-ku,Tokyo
1235.16.002 Boehringer Ingelheim Investigational Site
Suita, Osaka

Other trials in Japan

About this study

To assess the long term safety and efficacy of telmisartan plus amlodipine FDC in patients with essential hypertension who failed to control their BP with either monotherapy

Conditions: Hypertension
Being tested: telmisartan40/amlodipine5, telmisartan80/amlodipine5
Medical subject headings: Hypertension

What participants receive

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

telmisartan40/amlodipine5Drug
telmisartan80/amlodipine5Drug

What is being measured

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

Percentage of Participants Who Experienced Adverse Events
An adverse event is defined as any untoward medical occurrence
Measured: 52 weeks
Clinically Relevant Abnormalities for Changes in Blood Pressure and Pulse Rate Due to Position Change, Seated Pulse Rate, Laboratory Parameters and ECG
Clinically 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 study treatment to 24 hours post last dosing of study treatment.

Secondary outcomes (11)

Change From Baseline in Seated Diastolic Blood Pressure at Week 8
mean reduction from pseud-baseline (after the washout) in seated diastolic blood pressure
Measured: Baseline and week 8
Change From Baseline in Seated Systolic Blood Pressure at Week 8
mean reduction from pseud-baseline (after the washout) in seated systolic blood pressure
Measured: Baseline and week 8
Seated DBP Control Rate at Trough After 8 Weeks
Percentage of patients whose DBP <90 mmHg after 8 weeks of treatment
Measured: week 8
Seated SBP Control Rate at Trough After 8 Weeks
Percentage of patients whose SBP <140 mmHg after 8 weeks of treatment
Measured: Week 8
Change From Baseline in Seated Diastolic Blood Pressure
Mean reduction from pseud-baseline (after the washout) in seated diastolic blood pressure
Measured: Baseline and week 20 / week 48
Change From Baseline in Seated Systolic Blood Pressure
mean reduction from pseud-baseline (after the washout) in seated systolic blood pressure
Measured: Baseline and week 20 / week 48
Seated DBP Control Rate at Trough After 6 and 12 Months
Percentage of patients whose DBP <90 mmHg.
Measured: 6 months and 12 months
Seated SBP Control Rate at Trough After 6 and 12 Months
Percentage of patients whose SBP <140 mmHg
Measured: 6 months and 12 months
Seated DBP Response Rate at Trough
Percentage of patients whose DBP <90 mmHg or decreased from pseudo-baseline by >=10 mmHg at 6 months and 12 months
Measured: 6 months and 12 months
Seated SBP Response Rate at Trough
Percentage of patients whose SBP <140 mmHg or decreased deom pseudo-baseline by >=20 mmHg after 6 and 12 months
Measured: 6 months and 12 months
Seated Blood Pressure Normalisation at Trough
Percentage of patients when classifying their blood pressure measurements into the following classes at 6 and 12 months:
Optimal: SBP <120 mmHg and DBP <80 mmHg
Normal: SBP >=120 mmHg or DBP >=80 mmHg and SBP <130 mmHg or DBP <85 mmHg
High normal: SBP >=130 mmHg or DBP >=85 mmHg and SBP <140 mmHg or DBP <90 mmHg
No: SBP >=140 mmHg or DBP >=90 mmHg
Measured: 6 months and 12 months

Timeline

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

Jan 2008Oct 2009

First posted20 Feb 2008 (estimated)
Study startJan 2008
Primary completionOct 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
Intervention model: Parallel groups
Enrolment: 259 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00618774
Sponsor's protocol ID: 1235.16
Status last verified: Apr 2014
First submitted: 8 Feb 2008
Last updated: 27 Jun 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 27 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, Long-term Study of Telmisartan Plus Amlodipine Fixed-dose Combination
ClinicalTrials.gov ID: NCT00618774
Acronym / sponsor ID: 1235.16
Conditions: Hypertension
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 259 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Jan 2008
Primary completion: Oct 2009 (actual)
First posted: 20 Feb 2008 (estimated)
Results: Posted 3 Mar 2010

Clinical summary

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

To assess the long term safety and efficacy of telmisartan plus amlodipine FDC in patients with essential hypertension who failed to control their BP with either monotherapy

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 (2 listed)

Patients with essential hypertension
Outpatient

Key exclusion criteria (2 listed)

Patients whose SBP >=180 mmHg or DBP >=110 mmHg at the end of treatment visit of the double-blind treatment period in the "non-responder trials"
Patients who have met any of the exclusion criteria defined in the "non-responder trials"

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
telmisartan40/amlodipine5	Drug	–
telmisartan80/amlodipine5	Drug	–

Primary outcome

Percentage of Participants Who Experienced Adverse Events
Time frame: 52 weeks
An adverse event is defined as any untoward medical occurrence
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 study treatment to 24 hours post last dosing of study treatment.
Clinically 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.

11 secondary outcomes

Change From Baseline in Seated Diastolic Blood Pressure at Week 8
Time frame: Baseline and week 8
Change From Baseline in Seated Systolic Blood Pressure at Week 8
Time frame: Baseline and week 8
Seated DBP Control Rate at Trough After 8 Weeks
Time frame: week 8
Seated SBP Control Rate at Trough After 8 Weeks
Time frame: Week 8
Change From Baseline in Seated Diastolic Blood Pressure
Time frame: Baseline and week 20 / week 48
Change From Baseline in Seated Systolic Blood Pressure
Time frame: Baseline and week 20 / week 48
Seated DBP Control Rate at Trough After 6 and 12 Months
Time frame: 6 months and 12 months
Seated SBP Control Rate at Trough After 6 and 12 Months
Time frame: 6 months and 12 months
Seated DBP Response Rate at Trough
Time frame: 6 months and 12 months
Seated SBP Response Rate at Trough
Time frame: 6 months and 12 months
Seated Blood Pressure Normalisation at Trough
Time frame: 6 months and 12 months

Results and safety

Results posted to the registry on 3 Mar 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	211	205
Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination	48	45

Primary outcome: Percentage of Participants Who Experienced Adverse Events

Time frame: 52 weeks. Number. Unit: percentage of participants

Measure	Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination n = 211	Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination n = 48
Value	77.3	77.1

Population analysed: Treated set for safety, which was the analysis set including all the patients who had valid measurements after drug administration.

Primary outcome: 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 study treatment to 24 hours post last dosing of study treatment.. Number. Unit: participants

Measure	Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination n = 211	Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination n = 48
Blood Pressure Decreased	2	0
Prostatic specific antigen increased	1	0
Acute myocardial infarction	0	1
Arrhythmia	1	0
Atrial fibrillation	2	0
Extrasystoles	1	0
Ventricular extrasystoles	1	0
Orthostatic hypotension	0	1

Population analysed: Treated set

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: While being treated with T20+A5, T40/A5, T80/A5, T40/A5+additional treatment, T80/A5+additional treatment and within 24 hours from the last dosing of any of them.. 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	9 of 211 (4.3%)	102 of 211 (48.3%)	Not reported
Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination	3 of 48 (6.3%)	23 of 48 (47.9%)	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.
Related InfoLink provided by the sponsor.

Related trials for Hypertension

Active, not recruiting
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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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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

7 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 telmisartan40/amlodipine5 and telmisartan80/amlodipine5 in people with Hypertension, run by Boehringer Ingelheim at 7 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 2 inclusion and 2 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 7 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 3 Mar 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?

Percentage of Participants Who Experienced Adverse Events (time frame: 52 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 NCT00618774.

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.