HypertensionPhase 3NCT01975246

Add-on to Micamlo BP Trial

A Phase 3 study testing Telmisartan + amlodipine and hydrochlorothiazide in people with Hypertension, run by Boehringer Ingelheim at 30 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

Who is it for?: Ages 20 to 100 years
Conditions the study is for: Hypertension
What is being tested?: Telmisartan + amlodipine and hydrochlorothiazide
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 309 participants
Where: 30 sitesJapan
Study dates: Nov 2013to Jul 2014
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

30 sites in 1 country.

City, postcode or hospital

30 sites in 1 country

Japan30 sites

1348.1.015 Boehringer Ingelheim Investigational Site
Atsubetsu-ku,Sapporo,Hokkaido
1348.1.006 Boehringer Ingelheim Investigational Site
Bunkyo-ku, Tokyo
1348.1.002 Boehringer Ingelheim Investigational Site
Chiyoda-ku, Tokyo
1348.1.005 Boehringer Ingelheim Investigational Site
Chiyoda-ku, Tokyo
1348.1.031 Boehringer Ingelheim Investigational Site
Chiyoda-ku, Tokyo
1348.1.030 Boehringer Ingelheim Investigational Site
Chuo-ku, Tokyo
1348.1.033 Boehringer Ingelheim Investigational Site
Chuo-ku, Tokyo
1348.1.016 Boehringer Ingelheim Investigational Site
Chuo-ku,Sapporo,Hokkaido
1348.1.021 Boehringer Ingelheim Investigational Site
Chuo-ku,Tokyo
1348.1.024 Boehringer Ingelheim Investigational Site
Itabashi-ku, Tokyo
1348.1.028 Boehringer Ingelheim Investigational Site
Itoshima, Fukuoka
1348.1.027 Boehringer Ingelheim Investigational Site
Katsushika-ku, Tokyo
1348.1.001 Boehringer Ingelheim Investigational Site
Kishiwada, Osaka
1348.1.009 Boehringer Ingelheim Investigational Site
Kita-ku, Osaka
1348.1.029 Boehringer Ingelheim Investigational Site
Kita-ku, Osaka
1348.1.014 Boehringer Ingelheim Investigational Site
Kiyose,Tokyo
1348.1.003 Boehringer Ingelheim Investigational Site
Koto-ku, Tokyo
1348.1.022 Boehringer Ingelheim Investigational Site
Mihama-ku, Chiba, Chiba
1348.1.004 Boehringer Ingelheim Investigational Site
Miyagino-ku, Sendai, Miyagi
1348.1.017 Boehringer Ingelheim Investigational Site
Moriya, Ibaraki
1348.1.013 Boehringer Ingelheim Investigational Site
Naka-ku,Yokohama,Kanagawa
1348.1.018 Boehringer Ingelheim Investigational Site
Nishi-ku, Fukuoka, Fukuoka
1348.1.007 Boehringer Ingelheim Investigational Site
Okinawa, Okinawa
1348.1.020 Boehringer Ingelheim Investigational Site
Sakaide, Kagawa
1348.1.025 Boehringer Ingelheim Investigational Site
Sapporo, Hokkaido
1348.1.026 Boehringer Ingelheim Investigational Site
Sapporo, Hokkaido
1348.1.008 Boehringer Ingelheim Investigational Site
Suita, Osaka
1348.1.032 Boehringer Ingelheim Investigational Site
Suita, Osaka
1348.1.019 Boehringer Ingelheim Investigational Site
Takamatsu, Kagawa
1348.1.023 Boehringer Ingelheim Investigational Site
Toshima-ku, Tokyo

Other trials in Japan

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 Amlodipine 5 mg in Patients With Hypertension Who Fail to Respond Adequately to Treatment With Telmisartan 80 mg and Amlodipine 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+ amlodipine 5 mg (T80/A5 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+ amlodipine 5 mg. Patients are assigned to one of the two groups after a 6-week open-label run-in period taking T80/A5 mg.

Conditions: Hypertension
Being tested: Telmisartan + amlodipine, hydrochlorothiazide, Placebo
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
FDC tablet
hydrochlorothiazideDrug
tablet
Telmisartan + amlodipineDrug
FDC tablet
PlaceboDrug
placebo matching hydrochlorothiazide tablet

Study groups in NCT01975246
Study group	Role	What they receive
Telmisartan+amlodipine+HCTZ	Experimental	telmisartan 80 mg + amlodipine 5 mg fixed dose combination (FDC) and hydrochlorothiazide (HCTZ) 12.5 mg tablet Receives: Drug: Telmisartan + amlodipine; Drug: hydrochlorothiazide
Telmisartan+amlodipine	Active comparator	telmisartan 80 mg + amlodipine 5 mg fixed dose combination (FDC) and placebo matching hydrochlorothiazide 12.5 mg tablet Receives: Drug: Telmisartan + amlodipine; Drug: Placebo

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 after 8 weeks of the double-blind period. After patients had rested in a seated position for approximately 5 minutes, blood pressure was measured 3 times at approximately 2-minute intervals. The mean of the 3 measurements are used as endpoints.
Measured: baseline and week 8

Secondary outcomes (2)

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. After patients had rested in a seated position for approximately 5 minutes, blood pressure was measured 3 times at approximately 2-minute intervals. The mean of the 3 measurements are used as endpoints.
Measured: baseline and week 8
The Proportion of Patients With DBP<90 mmHg and SBP<140 mmHg as Seated Blood Pressure at Trough After 8 Weeks of the Double-blind Period
Patients with trough seated DBP =>90 mmHg or trough seated SBP >=140 mmHg at baseline were analysed.
Measured: baseline and week 8

Timeline

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

Nov 2013Jul 2014

First posted4 Nov 2013 (estimated)
Study startNov 2013
Primary completionJun 2014
Study completionJul 2014

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: 309 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01975246
Sponsor's protocol ID: 1348.1
Status last verified: Oct 2016
First submitted: 29 Oct 2013
Last updated: 29 Nov 2016
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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Electronic Alert to Improve Testing For Primary Aldosteronism in Patients With Hypertension
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A Clinical Study of to Confirm the Doses of Selexipag in Children With Pulmonary Arterial Hypertension
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A Study to Lower Blood Pressure One Year After Childbirth in Women Who Had Preeclampsia
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Controlled Remote Monitoring and Optimization of Oxygen Therapy in Preterm Infants
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All Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Nov 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 Amlodipine 5 mg in Patients With Hypertension Who Fail to Respond Adequately to Treatment With Telmisartan 80 mg and Amlodipine 5 mg
ClinicalTrials.gov ID: NCT01975246
Acronym / sponsor ID: 1348.1
Conditions: Hypertension
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 309 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Nov 2013
Primary completion: Jun 2014 (actual)
Study completion: Jul 2014 (actual)
First posted: 4 Nov 2013 (estimated)
Results: Posted 29 Nov 2016

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
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Number of arms: 2

Arm	Type	Receives
Telmisartan+amlodipine+HCTZ	Experimental	Drug: Telmisartan + amlodipine, Drug: hydrochlorothiazidetelmisartan 80 mg + amlodipine 5 mg fixed dose combination (FDC) and hydrochlorothiazide (HCTZ) 12.5 mg tablet
Telmisartan+amlodipine	Active comparator	Drug: Telmisartan + amlodipine, Drug: Placebotelmisartan 80 mg + amlodipine 5 mg fixed dose combination (FDC) and placebo matching hydrochlorothiazide 12.5 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
Telmisartan + amlodipineFDC tablet	Drug	Telmisartan+amlodipine+HCTZ
hydrochlorothiazidetablet	Drug	Telmisartan+amlodipine+HCTZ
Telmisartan + amlodipineFDC tablet	Drug	Telmisartan+amlodipine
Placeboplacebo matching hydrochlorothiazide tablet	Drug	Telmisartan+amlodipine

Primary outcome

Change From Baseline in Mean Seated DBP at Trough After 8 Weeks of the Double-blind Period.
Time frame: baseline and week 8
Change from baseline in mean seated diastolic blood pressure (DBP) at trough after 8 weeks of the double-blind period. After patients had rested in a seated position for approximately 5 minutes, blood pressure was measured 3 times at approximately 2-minute intervals. The mean of the 3 measurements are used as endpoints.

2 secondary outcomes

Change From Baseline in Mean Seated SBP at Trough After 8 Weeks of the Double-blind Period.
Time frame: baseline and week 8
The Proportion of Patients With DBP<90 mmHg and SBP<140 mmHg as Seated Blood Pressure at Trough After 8 Weeks of the Double-blind Period
Time frame: baseline and week 8

Results and safety

Results posted to the registry on 29 Nov 2016, 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 and Amlodipine+HCTZ	149	145
Telmisartan+Amlodipine	160	158

Primary outcome: Change From Baseline in Mean Seated DBP at Trough After 8 Weeks of the Double-blind Period.

Time frame: baseline and week 8. Mean (Standard Error). Unit: mmHg

Measure	Telmisartan and Amlodipine+HCTZ n = 147	Telmisartan+Amlodipine n = 160
Value	-8.4 (0.5)	-4.5 (0.5)

Telmisartan and Amlodipine+HCTZ vs Telmisartan+Amlodipine: Mean Difference (Final Values): -3.9 (95% CI -5.3 to -2.4), p <0.0001, ANCOVA

Population analysed: Full analysis set (FAS): This analysis set was, conforming to the intent-to-treat principle, defined as all patients i) included in the treated set; and ii) taking measurements of seated DBP at reference baseline and at 1 or more time points during the double-blind period.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first drug administration until 24 hours after the last drug administration, up to 71 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Telmisartan and Amlodipine+HCTZ	0 of 149 (0%)	36 of 149 (24.2%)	Not reported
Telmisartan+Amlodipine	0 of 160 (0%)	14 of 160 (8.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Hypertension

RecruitingObservational study
Genetics of Type 2 Diabetes in West Africans
Hypertension, Diabetes
Active, not recruiting
Electronic Alert to Improve Testing For Primary Aldosteronism in Patients With Hypertension
Primary Aldosteronism, Resistant Hypertension
Active, not recruitingPhase 2
A Clinical Study of to Confirm the Doses of Selexipag in Children With Pulmonary Arterial Hypertension
Pulmonary Arterial Hypertension
Not yet recruiting
A Study to Lower Blood Pressure One Year After Childbirth in Women Who Had Preeclampsia
Adverse Pregnancy Outcomes, Cardiovascular Diseases
Recruiting
Controlled Remote Monitoring and Optimization of Oxygen Therapy in Preterm Infants
BPD - Bronchopulmonary Dysplasia, Pulmonary Hypertension

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

30 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 hydrochlorothiazide in people with Hypertension, run by Boehringer Ingelheim at 30 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 29 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 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 29 Nov 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 week 8). 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 NCT01975246.

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 29 Nov 2016.