HypertensionPhase 3NCT01286558
Comparison in Japan T80/A5 (Telmisartan 80 mg and Amlodipine 5 mg) and T40/A5 (Telmisartan 40 mg and Amlodipine 5 mg)
A Phase 3 study testing 40 mg telmisartan, 5 mg amlodipine and 80 mg telmisartan in people with Hypertension, run by Boehringer Ingelheim at 8 sites in Japan.
Trial summary
Blood pressure in hypertensive patients is rarely controlled to an optimal level by one drug alone, often a combination of two or more drugs is essential to achieve a sufficient antihypertensive effect. Therefore in Japanese Society of Hypertension (JSH) 2009 combination therapy is recommended. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- 40 mg telmisartan, 5 mg amlodipine and 80 mg telmisartan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 8 sitesJapan
- Study dates
- Jan 2011to Sep 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 20 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Essential hypertensive patients
- If already taking antihypertensive drugs, mean seated diastolic blood pressure (DBP) must be >=90 and >=114 mmHg
- If not taking any antihypertensive drugs, mean seated DBP must be >=95 and >=114 mmHg
- Able to stop all current antihypertensive drugs without risk to the patient based on the investigators opinion.
Who cannot join
- Patients taking 3 or more antihypertensive drugs at signing the informed consent form
- Patients with known or suspected secondary hypertension
- Patients with clinically relevant cardiac arrhythmia
- Congestive heart failure with New York Heart Association (NYHA) functional class III-IV
- Patients with recent cardiovascular events
- Patients with a history of stroke or transient ischaemic attack within last 6 months before signing the informed consent form
Show all 11Show fewer
- Patients with a history of sudden deterioration of renal function with angiotensin II receptor blockers (ARBs) or angiotensin converting enzyme (ACE) inhibitors; or patients with post-renal transplant or post-nephrectomy
- Patients who have previously experienced characteristic symptoms of angioedema (such as facial, tongue, pharyngeal, or laryngeal swelling with dyspnea) during treatment with ARBs or ACE inhibitors
- Patients with known hypersensitivity to any component of the investigational product, or a known hypersensitivity to dihydropyridine-derived drugs
- Patients with hepatic and/or renal dysfunction
- Pre-menopausal women who are nursing or pregnant
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Japan8 sites
1235.37.01 Boehringer Ingelheim Investigational Site
Chuo-ku,Tokyo
1235.37.07 Boehringer Ingelheim Investigational Site
Hiroshima, Hiroshima
1235.37.08 Boehringer Ingelheim Investigational Site
Itoshima, Fukuoka
1235.37.02 Boehringer Ingelheim Investigational Site
Katsushika-ku, Tokyo
1235.37.05 Boehringer Ingelheim Investigational Site
Osaka, Osaka
1235.37.03 Boehringer Ingelheim Investigational Site
Ota-ku, Tokyo
1235.37.06 Boehringer Ingelheim Investigational Site
Suita, Osaka
1235.37.04 Boehringer Ingelheim Investigational Site
Yokohama, Kanagawa
About this study
Official title: An Eight-week Randomised Double-blind Study to Compare the Efficacy and Safety of Telmisartan 80mg Plus Amlodipine 5 mg Fixed-dose Combination vs. Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination in Patients With Hypertension
Blood pressure in hypertensive patients is rarely controlled to an optimal level by one drug alone, often a combination of two or more drugs is essential to achieve a sufficient antihypertensive effect. Therefore in Japanese Society of Hypertension (JSH) 2009 combination therapy is recommended. In JSH 2009 it is advised to start the combination therapy at a low dose, and to increase the dosage when the antihypertensive effect is not sufficient. In the Japanese long-term safety study, 259 patients received the T40/A5 mg fixed-dose combination (FDC), and after 6 weeks treatment 48 patients of them could not control their blood pressure (DBP =90) (U09-2494-01). For those patients who cannot control their blood pressure with T40/A5 mg FDC, a switch to a higher dose such as T80/A5 mg is recommended.
In the overseas 4x4 factorial design trial, a clinically meaningful difference of the blood pressure lowering effect between T80/A5 mg free combination and T40/A5 mg free combination was shown (U07-3503-02). But the sponsor has no data that verifies this difference in Japanese patients.
Thus, this clinical trial is being conducted to investigate the antihypertensive effect and safety of high dose T80/A5 mg FDC compared with low dose T40/A5 mg FDC in Japanese patients with essential hypertension. In this trial, a multi-centre, randomised, double-blind, double-dummy, active-controlled, parallel group comparison method is employed.
- Conditions
- Hypertension
- Being tested
- 40 mg telmisartan, 5 mg amlodipine, 80 mg telmisartan
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
40 mg telmisartanDrug
once daily
5 mg amlodipineDrug
once daily
5 mg amlodipineDrug
once daily
80 mg telmisartanDrug
once daily
| Study group | Role | What they receive |
|---|---|---|
| 80mg telmisartan and 5mg amlodipine FDC | Experimental | once daily Receives: Drug: 5 mg amlodipine; Drug: 80 mg telmisartan |
| 40mg telmisartan and 5mg amlodipine FDC | Active comparator | once daily Receives: Drug: 40 mg telmisartan; Drug: 5 mg amlodipine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction From the Reference Baseline in Mean Seated Diastolic Blood Pressure (DBP) at Trough
Reference baseline: Status of patients after the 12-week open-label run-in period with telmisartan monotherapy followed by 40 mg telmisartan and 5 mg amlodipine combination therapy, where patients' eligibility to enter the double-blind treatment period was examined At trough: 24-hour post-dosing
Measured: Reference baseline, 8 weeks
Secondary outcomes (12)
Reduction From the Reference Baseline in Mean Seated Systolic Blood Pressure (SBP) at Trough
Reference baseline: Status of patients after the 12-week open-label run-in period with telmisartan monotherapy followed by 40 mg telmisartan and 5 mg amlodipine combination therapy, where patients' eligibility to enter the double-blind treatment period was examined At trough: 24-hour post-dosing
Measured: Reference baseline, 8 weeks
Changes From the Reference Baseline in the 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Mean (Relative to Dose Time) for DBP
Reference baseline: Status of patients after the 12-week open-label run-in period with telmisartan monotherapy followed by 40 mg telmisartan and 5 mg amlodipine combination therapy, where patients' eligibility to enter the double-blind treatment period was examined
Measured: Reference baseline, 8 weeks
Changes From the Reference Baseline in the 24-hour ABPM Mean (Relative to Dose Time) for SBP
Reference baseline: Status of patients after the 12-week open-label run-in period with telmisartan monotherapy followed by 40 mg telmisartan and 5 mg amlodipine combination therapy, where patients' eligibility to enter the double-blind treatment period was examined
Measured: Reference baseline, 8 weeks
Changes From the Pseudo-baseline in the 24-hour ABPM Mean (Relative to Dose Time) for DBP
Pseudo-baseline: Status of patients after the 6-week open-label run-in period with telmisartan monotherapy, where patients' eligibility to enter the double-blind treatment period was examined
Measured: Pseudo-baseline, 14 weeks
Changes From the Pseudo-baseline in the 24-hour ABPM Mean (Relative to Dose Time) for SBP
Pseudo-baseline: Status of patients after the 6-week open-label run-in period with telmisartan monotherapy, where patients' eligibility to enter the double-blind treatment period was examined
Measured: Pseudo-baseline, 14 weeks
Changes From the Reference Baseline in DBP Hourly Mean Over the 24-hour Dosing Interval as Measured by ABPM
Reference baseline: Status of patients after the 12-week open-label run-in period with telmisartan monotherapy followed by 40 mg telmisartan and 5 mg amlodipine combination therapy, where patients' eligibility to enter the double-blind treatment period was examined
Measured: Reference baseline, 8 weeks
Changes From the Reference Baseline in SBP Hourly Mean Over the 24-hour Dosing Interval as Measured by ABPM
Reference baseline: Status of patients after the 12-week open-label run-in period with telmisartan monotherapy followed by 40 mg telmisartan and 5 mg amlodipine combination therapy, where patients' eligibility to enter the double-blind treatment period was examined
Measured: Reference baseline, 8 weeks
Seated DBP Control Rate at Trough
DBP control rate: The rate of patients with controlled seated DBP at trough of less than 90 mmHg after the 8-week double-blind period At trough: 24-hour post-dosing
Measured: 8 weeks
Seated SBP Control Rate at Trough
SBP control rate: The rate of patients with controlled seated DBP at trough of less than 140 mmHg after the 8-week double-blind period At trough: 24-hour post-dosing
Measured: 8 weeks
Seated DBP Response Rate at Trough
DBP response rate: The rate of patients who achieved an adequate response in seated DBP at trough (<90 mmHg and/or reduction from reference baseline >=10 mmHg) after the 8-week double-blind period At trough: 24-hour post-dosing
Measured: 8 weeks
Seated SBP Response Rate at Trough
SBP response rate: The rate of patients who achieved an adequate response in seated SBP at trough (<140 mmHg and/or reduction from reference baseline >=20 mmHg) after the 8-week double-blind period At trough: 24-hour post-dosing
Measured: 8 weeks
Seated Blood Pressure (BP) Normalisation at Trough
Seated blood pressure (BP) normalisation: The numbers of patients whose blood pressure was within normalisation criterion in terms of seated blood pressure after the 8-week double-blind period At trough: 24-hour post-dosing
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionSep 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.
- 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
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01286558
- Sponsor's protocol ID
- 1235.37
- Status last verified
- Jan 2014
- First submitted
- 28 Jan 2011
- Last updated
- 27 Jun 2014
- Results posted
- Yes, on ClinicalTrials.gov
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 Eight-week Randomised Double-blind Study to Compare the Efficacy and Safety of Telmisartan 80mg Plus Amlodipine 5 mg Fixed-dose Combination vs. Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination in Patients With Hypertension
- ClinicalTrials.gov ID
- NCT01286558
- Acronym / sponsor ID
- 1235.37
- Conditions
- Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Sep 2011 (actual)
- First posted
- 31 Jan 2011 (estimated)
- Results
- Posted 22 Oct 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Blood pressure in hypertensive patients is rarely controlled to an optimal level by one drug alone, often a combination of two or more drugs is essential to achieve a sufficient antihypertensive effect. Therefore in Japanese Society of Hypertension (JSH) 2009 combination therapy is recommended. In JSH 2009 it is advised to start the combination therapy at a low dose, and to increase the dosage when the antihypertensive effect is not sufficient. In the Japanese long-term safety study, 259 patients received the T40/A5 mg fixed-dose combination (FDC), and after 6 weeks treatment 48 patients of them could not control their blood pressure (DBP =90) (U09-2494-01). For those patients who cannot control their blood pressure with T40/A5 mg FDC, a switch to a higher dose such as T80/A5 mg is recommended.
In the overseas 4x4 factorial design trial, a clinically meaningful difference of the blood pressure lowering effect between T80/A5 mg free combination and T40/A5 mg free combination was shown (U07-3503-02). But the sponsor has no data that verifies this difference in Japanese patients.
Thus, this clinical trial is being conducted to investigate the antihypertensive effect and safety of high dose T80/A5 mg FDC compared with low dose T40/A5 mg FDC in Japanese patients with essential hypertension. In this trial, a multi-centre, randomised, double-blind, double-dummy, active-controlled, parallel group comparison method is employed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 80mg telmisartan and 5mg amlodipine FDC | Experimental | Drug: 5 mg amlodipine, Drug: 80 mg telmisartanonce daily |
| 40mg telmisartan and 5mg amlodipine FDC | Active comparator | Drug: 40 mg telmisartan, Drug: 5 mg amlodipineonce daily |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Essential hypertensive patients
- Able to stop all current antihypertensive drugs without risk to the patient based on the investigators opinion.
Key exclusion criteria (11 listed)
- Patients taking 3 or more antihypertensive drugs at signing the informed consent form
- Patients with known or suspected secondary hypertension
- Patients with clinically relevant cardiac arrhythmia
- Congestive heart failure with New York Heart Association (NYHA) functional class III-IV
- Patients with recent cardiovascular events
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 |
|---|---|---|
| 40 mg telmisartanonce daily | Drug | 40mg telmisartan and 5mg amlodipine FDC |
| 5 mg amlodipineonce daily | Drug | 80mg telmisartan and 5mg amlodipine FDC |
| 5 mg amlodipineonce daily | Drug | 40mg telmisartan and 5mg amlodipine FDC |
| 80 mg telmisartanonce daily | Drug | 80mg telmisartan and 5mg amlodipine FDC |
Primary outcome
Reduction From the Reference Baseline in Mean Seated Diastolic Blood Pressure (DBP) at Trough
Time frame: Reference baseline, 8 weeks
Reference baseline: Status of patients after the 12-week open-label run-in period with telmisartan monotherapy followed by 40 mg telmisartan and 5 mg amlodipine combination therapy, where patients' eligibility to enter the double-blind treatment period was examined At trough: 24-hour post-dosing
12 secondary outcomes
Reduction From the Reference Baseline in Mean Seated Systolic Blood Pressure (SBP) at Trough
Time frame: Reference baseline, 8 weeks
Changes From the Reference Baseline in the 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Mean (Relative to Dose Time) for DBP
Time frame: Reference baseline, 8 weeks
Changes From the Reference Baseline in the 24-hour ABPM Mean (Relative to Dose Time) for SBP
Time frame: Reference baseline, 8 weeks
Changes From the Pseudo-baseline in the 24-hour ABPM Mean (Relative to Dose Time) for DBP
Time frame: Pseudo-baseline, 14 weeks
Changes From the Pseudo-baseline in the 24-hour ABPM Mean (Relative to Dose Time) for SBP
Time frame: Pseudo-baseline, 14 weeks
Changes From the Reference Baseline in DBP Hourly Mean Over the 24-hour Dosing Interval as Measured by ABPM
Time frame: Reference baseline, 8 weeks
Changes From the Reference Baseline in SBP Hourly Mean Over the 24-hour Dosing Interval as Measured by ABPM
Time frame: Reference baseline, 8 weeks
Seated DBP Control Rate at Trough
Time frame: 8 weeks
Seated SBP Control Rate at Trough
Time frame: 8 weeks
Seated DBP Response Rate at Trough
Time frame: 8 weeks
Seated SBP Response Rate at Trough
Time frame: 8 weeks
Seated Blood Pressure (BP) Normalisation at Trough
Time frame: 8 weeks
Results and safety
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 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
8 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 40 mg telmisartan, 5 mg amlodipine and 80 mg telmisartan in people with Hypertension, run by Boehringer Ingelheim at 8 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 11 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 8 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 22 Oct 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?
Reduction From the Reference Baseline in Mean Seated Diastolic Blood Pressure (DBP) at Trough (time frame: Reference baseline, 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.