HypertensionPhase 3NCT01204398
Telmisartan+Amlodipine Fixed Dose Combination in Hypertension
A Phase 3 study testing telmisartan+amlodipine fixed dose combination in people with Hypertension, run by Boehringer Ingelheim at 1 site in China.
Trial summary
The primary objectives of this trial is to evaluate the changes from baseline (Visit 2) in the 24-hour Ambulatory Blood Pressure Monitoring mean (relative to dose time) for diastolic blood pressure and systolic blood pressure after 8 weeks of treatment with Telmisartan 80mg/Amlodipine 5mg in patients with moderate to… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypertension
- What is being tested?
- telmisartan+amlodipine fixed dose combination
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteChina
- Study dates
- Nov 2010to Jul 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged at least 18 years at the date of signing the consent form
- For treatment-naïve patients: hypertension defined by a mean seated diastolic blood pressure (DBP) equal or more than 100 mmHg measured by manual cuff sphygmomanometry at visit 1 and 2; For pretreatment patients: hypertension defined by a mean seated diastolic blood pressure equal or more than 90 mmHg at visit 1 and equal or more than 100 mmHg at visit 2 measured by manual cuff sphygmomanometry
- 24-hour mean diastolic blood pressure equal or more than 85 mmHg at baseline Ambulatory Blood Pressure Monitoring
Who cannot join
- mean seated systolic blood pressure equal or more than 200 mmHg and/or mean seated diastolic blood pressure equal or more than 120 mmHg
- any clinically significant hepatic impairment
- severe renal impairment
- bilateral renal artery stenosis or renal artery stenosis in a solitary kidney or post-renal transplant
- current treatment with any antihypertensive agents, whether or not prescribed for this indication, that cannot be safely stopped
- other conditions or situations that could put potential participants at unacceptable risk due to participation in this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label Study to Evaluate the Antihypertensive Effects of the Fixed-dose Combination of Telmisartan 80 mg and Amlodipine 5 mg (T80/A5) Given Once Daily by 24 h ABPM in Patients With Moderate to Severe Hypertension
The primary objectives of this trial is to evaluate the changes from baseline (Visit 2) in the 24-hour Ambulatory Blood Pressure Monitoring mean (relative to dose time) for diastolic blood pressure and systolic blood pressure after 8 weeks of treatment with Telmisartan 80mg/Amlodipine 5mg in patients with moderate to severe hypertension
- Conditions
- Hypertension
- Being tested
- telmisartan+amlodipine fixed dose combination
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
telmisartan+amlodipine fixed dose combinationDrug
after 2 weeks placebo wash-out, patients will be administered Telmisartan 80mg/Amlodipine 5mg for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| eligible hypertension patient | Experimental | Patients will be given placebo for 2 weeks for wash-out, then qualified patients will be administered Telmisartan 80mg/Amlodipine 5mg for 8 weeks. Receives: Drug: telmisartan+amlodipine fixed dose combination |
What is being measured
The primary outcome is the main question the study is designed to answer.
DBP and SBP Change From Baseline in Mean 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Mean
ABPM measurements were taken every 20 minutes throughout the day and night by the validated SpaceLabs Model 90217 monitor.
Measured: 8 weeks
Secondary outcomes (6)
Change From Baseline in ABPM Hourly Mean DBP and SBP, Starting 1 Hour After Dosing
Changes from baseline in DBP and SBP hourly means over the 24-hour dosing interval as measured by ABPM after 8 weeks of treatment with T80/A5
Measured: 8 weeks
Trough to Peak (T/P) Ratio for DBP and SBP After 8 Weeks of Treatment
Calculated on the basis of changes in hourly means from baseline. Trough is defined as the mean of the last three hours of the 24-hour dosing interval. Peak is the greatest reduction in hourly means in hours 2 to 8 after dosing. All measurements are using ABPM.
Measured: 8 weeks
Change From Baseline to End of Study in DBP and SBP
Manually measured in-clinic DBP and SBP
Measured: 8 weeks
ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing
DBP and SBP hourly means over the 24-hour dosing interval as measured by ABPM at baseline and after 8 weeks of treatment
Measured: 0 and 8 weeks
Treatment Emergent Adverse Events
Electrocardiogram, laboratory parameters and physical examinations were performed and any abnormal findings were recorded within the adverse events
Measured: 8 weeks
Change From Baseline to End of Study in In-clinic Pulse Rate
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 posted17 Sep 2010 (estimated)
- Study startNov 2010
- Primary completionJul 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
- Single group
- Masking
- None (open label)
- Enrolment
- 27 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
- NCT01204398
- Sponsor's protocol ID
- 1235.31
- Status last verified
- Dec 2013
- First submitted
- 16 Sep 2010
- 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 Open-label Study to Evaluate the Antihypertensive Effects of the Fixed-dose Combination of Telmisartan 80 mg and Amlodipine 5 mg (T80/A5) Given Once Daily by 24 h ABPM in Patients With Moderate to Severe Hypertension
- ClinicalTrials.gov ID
- NCT01204398
- Acronym / sponsor ID
- 1235.31
- Conditions
- Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Jul 2011 (actual)
- First posted
- 17 Sep 2010 (estimated)
- Results
- Posted 24 Aug 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objectives of this trial is to evaluate the changes from baseline (Visit 2) in the 24-hour Ambulatory Blood Pressure Monitoring mean (relative to dose time) for diastolic blood pressure and systolic blood pressure after 8 weeks of treatment with Telmisartan 80mg/Amlodipine 5mg in patients with moderate to severe hypertension
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| eligible hypertension patient | Experimental | Drug: telmisartan+amlodipine fixed dose combinationPatients will be given placebo for 2 weeks for wash-out, then qualified patients will be administered Telmisartan 80mg/Amlodipine 5mg for 8 weeks. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged at least 18 years at the date of signing the consent form
- For treatment-naïve patients: hypertension defined by a mean seated diastolic blood pressure (DBP) equal or more than 100 mmHg measured by manual cuff sphygmomanometry at visit 1 and 2; For pretreatment patients: hypertension defined by a mean seated diastolic blood pressure equal or more than 90 mmHg at visit 1 and equal or more than 100 mmHg at visit 2 measured by manual cuff sphygmomanometry
- 24-hour mean diastolic blood pressure equal or more than 85 mmHg at baseline Ambulatory Blood Pressure Monitoring
Key exclusion criteria (6 listed)
- mean seated systolic blood pressure equal or more than 200 mmHg and/or mean seated diastolic blood pressure equal or more than 120 mmHg
- any clinically significant hepatic impairment
- severe renal impairment
- bilateral renal artery stenosis or renal artery stenosis in a solitary kidney or post-renal transplant
- current treatment with any antihypertensive agents, whether or not prescribed for this indication, that cannot be safely stopped
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 fixed dose combinationafter 2 weeks placebo wash-out, patients will be administered Telmisartan 80mg/Amlodipine 5mg for 8 weeks. | Drug | eligible hypertension patient |
Primary outcome
DBP and SBP Change From Baseline in Mean 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Mean
Time frame: 8 weeks
ABPM measurements were taken every 20 minutes throughout the day and night by the validated SpaceLabs Model 90217 monitor.
6 secondary outcomes
Change From Baseline in ABPM Hourly Mean DBP and SBP, Starting 1 Hour After Dosing
Time frame: 8 weeks
Trough to Peak (T/P) Ratio for DBP and SBP After 8 Weeks of Treatment
Time frame: 8 weeks
Change From Baseline to End of Study in DBP and SBP
Time frame: 8 weeks
ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing
Time frame: 0 and 8 weeks
Treatment Emergent Adverse Events
Time frame: 8 weeks
Change From Baseline to End of Study in In-clinic Pulse Rate
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
1 site 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 fixed dose combination in people with Hypertension, run by Boehringer Ingelheim at 1 site in China.
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 6 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 1 site in China. 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 24 Aug 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?
DBP and SBP Change From Baseline in Mean 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Mean (time frame: 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; AzTrials last refreshed its copy on 6 Nov 2026.