HypertensionPhase 3NCT01911780
Compare Efficacy and Safety of Telmisartan/Hydrochlorothiazide With Telmisartan/Hydrochlorothiazide Plus Amlodipine
A Phase 3 study testing telmisartan + HCTZ and amlodipine in people with Hypertension, run by Boehringer Ingelheim at 17 sites in Japan.
Trial summary
This is a multi-centre, randomised, double-blind, active-controlled, parallel-group comparative trial to compare the fixed dose combination (FDC) of telmisartan 80 mg + hydrochlorothiazide 12.5 mg and amlodipine 5 mg (T80/A5/H12.5 mg) to telmisartan 80 mg+ hydrochlorothiazide 12.5 mg (T80/H12.5 mg) in blood pressure… Read more about this study
- Who is it for?
- Ages 20 to 100 years
- Conditions the study is for
- Hypertension
- What is being tested?
- telmisartan + HCTZ and amlodipine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 17 sitesJapan
- Study dates
- Jul 2013to Jan 2015
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Essential hypertensive patients who have already taking 2 or 3 antihypertensive drugs and mean seated diastolic blood pressure (DBP) must be >=90 and <=114 mmHg and mean seated systolic blood pressure (SBP) must be =<200 mmHg
- Able to stop all current antihypertensive drugs (other than study medication) from Visit 1b through the end of the trial without risk to the patient based on the investigator's opinion
- Age 20 years or older
Who cannot join
- 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 recent stroke events
- Patients with a history of sudden deterioration of renal function with angiotensin II receptor blockers or angiotensin converting enzyme inhibitors; or patients with post-renal transplant or post-nephrectomy
- Patients with hepatic and/or renal dysfunction
- Pre-menopausal women who are nursing or pregnant
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
Japan17 sites
1348.2.020 Boehringer Ingelheim Investigational Site
Chiyoda-ku, Tokyo
1348.2.008 Boehringer Ingelheim Investigational Site
Chuo-ku, Fukuoka, Fukuoka
1348.2.018 Boehringer Ingelheim Investigational Site
Chuo-ku,Kobe, Hyogo
1348.2.006 Boehringer Ingelheim Investigational Site
Chuo-ku,Tokyo
1348.2.013 Boehringer Ingelheim Investigational Site
Chuo-ku,Tokyo
1348.2.021 Boehringer Ingelheim Investigational Site
Chuo-ku,Tokyo
1348.2.012 Boehringer Ingelheim Investigational Site
Hirakata, Osaka
1348.2.011 Boehringer Ingelheim Investigational Site
Kasaoka, Okayama
1348.2.001 Boehringer Ingelheim Investigational Site
Kawasaki, Kanagawa
1348.2.019 Boehringer Ingelheim Investigational Site
Kita-ku, Osaka-shi, Osaka
1348.2.014 Boehringer Ingelheim Investigational Site
Kiyota-ku, Sapporo-shi, Hokkaido
1348.2.002 Boehringer Ingelheim Investigational Site
Kumamoto, Kumamoto
1348.2.007 Boehringer Ingelheim Investigational Site
Nakano-ku,Tokyo
1348.2.009 Boehringer Ingelheim Investigational Site
Nishi-ku, Fukuoka, Fukuoka
1348.2.005 Boehringer Ingelheim Investigational Site
Takatsuki, Osaka
1348.2.016 Boehringer Ingelheim Investigational Site
Uji, Kyoto
1348.2.010 Boehringer Ingelheim Investigational Site
Yoshikawa, Saitama
About this study
Official title: An Eight-week Randomised Double-blind Study to Compare the Efficacy and Safety of Telmisartan 80 mg and Amlodipine 5 mg and Hydrochlorothiazide 12.5 mg vs. Telmisartan 80 mg and Hydrochlorothiazide 12.5 mg in Patients With Hypertension Who Fail to Respond Adequately to Treatment With Telmisartan 80 mg and Hydrochlorothiazide 12.5 mg, Followed by a 52 Weeks Extension Study to Assess Long Term Safety of Telmisartan 80 mg and Amlodipine 5 mg and Hydrochlorothiazide 12.5 mg
This is a multi-centre, randomised, double-blind, active-controlled, parallel-group comparative trial to compare the fixed dose combination (FDC) of telmisartan 80 mg + hydrochlorothiazide 12.5 mg and amlodipine 5 mg (T80/A5/H12.5 mg) to telmisartan 80 mg+ hydrochlorothiazide 12.5 mg (T80/H12.5 mg) in blood pressure lowering effect at week 8, the end of the double-blind period in essential hypertensive patients who fail to respond adequately to telmisartan 80 mg+ hydrochlorothiazide 12.5 mg.
Patients are assigned to one of the two groups after a 6-week open-label run-in period taking T80/H12.5 mg.
Read more
In addition the long-term safety of telmisartan 80 mg+ amlodipine 5 mg+ hydrochlorothiazide 12.5 mg will be evaluated in a 52-week extension period.
In the 52-week open label extension period patients who are assigned to the T80/A5/H12.5 mg group continue the T80/A5/H12.5 mg therapy, and patients who are assigned to the T80/ /H12.5 mg group change to the T80/A5/H12.5 mg therapy.
- Conditions
- Hypertension
- Being tested
- placebo, telmisartan + HCTZ, amlodipine
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboDrug
placebo matching amlodipine capsule
telmisartan + HCTZDrug
FDC tablet
telmisartan + HCTZDrug
FDC tablet
amlodipineDrug
capsule
| Study group | Role | What they receive |
|---|---|---|
| telmisartan + HCTZ + amlodipine | Experimental | telmisartan 80 mg + hydrochlorothiazide (HCTZ) 12.5 mg fixed dose combination (FDC) and amlodipine 5 mg capsule (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet) Receives: Drug: telmisartan + HCTZ; Drug: amlodipine |
| telmisartan + HCTZ + placebo | Active comparator | telmisartan 80 mg + HCTZ FDC tablet and placebo matching amlodipine 5 mg capsule (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet) Receives: Drug: placebo; Drug: telmisartan + HCTZ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Mean Seated DBP at Trough After 8 Weeks of the Double-blind Period.
Change from baseline in mean seated diastolic blood pressure (DBP) at trough (24-hour post dosing) after 8 weeks of the double-blind period. The results are presented as 'change' rather than 'reduction' i.e., reductions are expressed with negative values'. The 'adjusted mean' is shown as 'mean'.
Measured: baseline and 8 weeks
Secondary outcomes (5)
Change From Baseline in Mean Seated SBP at Trough After 8 Weeks of the Double-blind Period.
Change from baseline in mean seated systolic blood pressure (SBP) at trough after 8 weeks of the double-blind period. The results are presented as 'change' rather than 'reduction' i.e., reductions are expressed with negative values'. The 'adjusted mean' is shown as 'mean'.
Measured: baseline and 8 weeks
The Percentage of Patients With DBP<90 mmHg and SBP<140 mmHg Blood Pressure at Trough After 8 Weeks of Double-blind Period.
The percentage of patients with DBP<90 mmHg and SBP<140 mmHg as seated blood pressure at trough after 8 weeks of the double-blind period. The results are presented as 'change' rather than 'reduction' i.e., reductions are expressed with negative values'. The 'adjusted mean' is shown as 'mean'.
Measured: Double-blind and 8 weeks
The Number of Patients With DBP<90 mmHg and SBP<140 mmHg Blood Pressure at Trough After 52 Weeks of Extension Period.
The number of patients with DBP<90 mmHg and SBP<140 mmHg as seated blood pressure at trough after 52 weeks of the extension period. Note, week 52 of the extension period corresponds to 60 weeks after the reference baseline.
The results are presented as 'change' rather than 'reduction' i.e., reductions are expressed with negative values'. The 'adjusted mean' is shown as 'mean'.
Measured: Reference baseline (week 0) and week 60 (end of extension period)
Change From Baseline in Mean DBP Pressure at Trough After 52 Weeks of the Extension Period.
Change from baseline in mean seated diastolic blood pressure at trough after 52 weeks of the extension period. Note, week 52 of the extension period corresponds to 60 weeks after the reference baseline.
The results are presented as 'change' rather than 'reduction' i.e., reductions are expressed with negative values'. The 'adjusted mean' is shown as 'mean'.
Measured: Reference baseline (week 0) and week 60 (end of extension period)
Change From Baseline in Mean Seated SBP at Trough After 52 Weeks of the Extension Period.
Change from baseline in mean seated systolic blood pressure at trough after 52 weeks of the extension period. Note, week 52 of the extension period corresponds to 60 weeks after the reference baseline.
The results are presented as 'change' rather than 'reduction' i.e., reductions are expressed with negative values'. The 'adjusted mean' is shown as 'mean'.
Measured: Reference baseline (week 0) and week 60 (end of extension period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionJan 2015
- Study completionJan 2015
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
- 132 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
- NCT01911780
- Sponsor's protocol ID
- 1348.2
- Status last verified
- Feb 2016
- First submitted
- 26 Jul 2013
- Last updated
- 28 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2016. 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 80 mg and Amlodipine 5 mg and Hydrochlorothiazide 12.5 mg vs. Telmisartan 80 mg and Hydrochlorothiazide 12.5 mg in Patients With Hypertension Who Fail to Respond Adequately to Treatment With Telmisartan 80 mg and Hydrochlorothiazide 12.5 mg, Followed by a 52 Weeks Extension Study to Assess Long Term Safety of Telmisartan 80 mg and Amlodipine 5 mg and Hydrochlorothiazide 12.5 mg
- ClinicalTrials.gov ID
- NCT01911780
- Acronym / sponsor ID
- 1348.2
- Conditions
- Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 30 Jul 2013 (estimated)
- Results
- Posted 28 Mar 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multi-centre, randomised, double-blind, active-controlled, parallel-group comparative trial to compare the fixed dose combination (FDC) of telmisartan 80 mg + hydrochlorothiazide 12.5 mg and amlodipine 5 mg (T80/A5/H12.5 mg) to telmisartan 80 mg+ hydrochlorothiazide 12.5 mg (T80/H12.5 mg) in blood pressure lowering effect at week 8, the end of the double-blind period in essential hypertensive patients who fail to respond adequately to telmisartan 80 mg+ hydrochlorothiazide 12.5 mg.
Patients are assigned to one of the two groups after a 6-week open-label run-in period taking T80/H12.5 mg.
In addition the long-term safety of telmisartan 80 mg+ amlodipine 5 mg+ hydrochlorothiazide 12.5 mg will be evaluated in a 52-week extension period.
In the 52-week open label extension period patients who are assigned to the T80/A5/H12.5 mg group continue the T80/A5/H12.5 mg therapy, and patients who are assigned to the T80/ /H12.5 mg group change to the T80/A5/H12.5 mg therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| telmisartan + HCTZ + amlodipine | Experimental | Drug: telmisartan + HCTZ, Drug: amlodipinetelmisartan 80 mg + hydrochlorothiazide (HCTZ) 12.5 mg fixed dose combination (FDC) and amlodipine 5 mg capsule (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet) |
| telmisartan + HCTZ + placebo | Active comparator | Drug: placebo, Drug: telmisartan + HCTZtelmisartan 80 mg + HCTZ FDC tablet and placebo matching amlodipine 5 mg capsule (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet) |
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Essential hypertensive patients who have already taking 2 or 3 antihypertensive drugs and mean seated diastolic blood pressure (DBP) must be >=90 and <=114 mmHg and mean seated systolic blood pressure (SBP) must be =<200 mmHg
- Able to stop all current antihypertensive drugs (other than study medication) from Visit 1b through the end of the trial without risk to the patient based on the investigator's opinion
- Age 20 years or older
Key exclusion criteria (8 listed)
- 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 recent stroke 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 |
|---|---|---|
| placeboplacebo matching amlodipine capsule | Drug | telmisartan + HCTZ + placebo |
| telmisartan + HCTZFDC tablet | Drug | telmisartan + HCTZ + placebo |
| telmisartan + HCTZFDC tablet | Drug | telmisartan + HCTZ + amlodipine |
| amlodipinecapsule | Drug | telmisartan + HCTZ + amlodipine |
Primary outcome
Change From Baseline in Mean Seated DBP at Trough After 8 Weeks of the Double-blind Period.
Time frame: baseline and 8 weeks
Change from baseline in mean seated diastolic blood pressure (DBP) at trough (24-hour post dosing) after 8 weeks of the double-blind period. The results are presented as 'change' rather than 'reduction' i.e., reductions are expressed with negative values'. The 'adjusted mean' is shown as 'mean'.
5 secondary outcomes
Change From Baseline in Mean Seated SBP at Trough After 8 Weeks of the Double-blind Period.
Time frame: baseline and 8 weeks
The Percentage of Patients With DBP<90 mmHg and SBP<140 mmHg Blood Pressure at Trough After 8 Weeks of Double-blind Period.
Time frame: Double-blind and 8 weeks
The Number of Patients With DBP<90 mmHg and SBP<140 mmHg Blood Pressure at Trough After 52 Weeks of Extension Period.
Time frame: Reference baseline (week 0) and week 60 (end of extension period)
Change From Baseline in Mean DBP Pressure at Trough After 52 Weeks of the Extension Period.
Time frame: Reference baseline (week 0) and week 60 (end of extension period)
Change From Baseline in Mean Seated SBP at Trough After 52 Weeks of the Extension Period.
Time frame: Reference baseline (week 0) and week 60 (end of extension period)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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
17 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 + HCTZ and amlodipine in people with Hypertension, run by Boehringer Ingelheim at 17 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 3 inclusion and 8 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 28 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 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 28 Mar 2016). 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 Mean Seated DBP at Trough After 8 Weeks of the Double-blind Period. (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?
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 28 Mar 2016.