HypertensionPhase 3NCT02177409
Telmisartan Versus Amlodipine in Patients With Mild-to-Moderate Hypertension
A Phase 3 study testing Telmisartan and Amlodipine in people with Hypertension, run by Boehringer Ingelheim.
Trial summary
The primary aim of the trial is the effect of telmisartan versus amlodipine in lowering ambulatory diastolic and/or systolic blood pressures in the last six hours of the dosing interval in patients with mild-to-moderate hypertension as measured by ambulatory blood pressure monitoring (ABPM) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Telmisartan and Amlodipine
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 431 participants
- Where
- No sites listed yet
- Study dates
- Apr 1998to Dec 1998
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mild-to-moderate hypertension defined as a mean seated diastolic blood pressure (BP) of ≥ 95 mm Hg and ≤ 114 mm Hg, measured by manual cuff sphygmomanometer, on the last visit (Visit 6) of the four-week placebo run-in period (baseline BP)
- Mean seated systolic blood pressure ≥ 140 mm Hg and ≤ 200 mm Hg, measured by manual cuff at Visit 6 (baseline BP)
- A 24-hour mean ABPM measurement of ≥ 130/85 mm Hg evaluated at Visit 7 (baseline ABPM)
- Age 18 or older
- Ability to provide written informed consent
Who cannot join
- Pre-menopausal women (last menstruation ≤ 1 year prior to start of screening):
- who are not surgically sterile (hysterectomy, tubal ligation)
- who are NOT practicing acceptable means of birth control or who do NOT plan to continue using an acceptable method throughout the study
- Any women:
- Who has a positive serum pregnancy test at screening (Visit 1) or baseline (Visit 7)
- Who is nursing
Show all 28Show fewer
- Hepatic and/or renal dysfunction as defined by the following laboratory parameters
- SGPT (ALT) (serum glutamate pyruvate transaminase) or SGOT (AST) (serum glutamate oxaloacetate transaminase) greater than two times the upper limit of normal
- Serum creatinine > 2.3 mg/dL
- At screening (Visit 1): clinically relevant sodium depletion, hyperkalemia, or hypokalemia
- Known or suspected secondary hypertension
- Bilateral renal artery stenosis; renal artery stenosis in a solitary kidney; post-renal transplant patients, presence of only one functioning kidney
- Congestive heart failure (CHF) (NYHA (New York Heart Association) class CHF III-IV)
- Unstable angina within the past three months
- Stroke within the past six months
- Myocardial infarction or cardiac surgery within the past three months
- PTCA (percutaneous transluminal coronary angioplasty) within the past three months
- History of angioedema
- Sustained ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant cardiac arrhythmias as determined by the investigator
- Hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically relevant stenosis of the aortic or mitral valve
- Administration of digoxin or other digitalis-type drugs
- Patients with insulin-dependent diabetes mellitus whose diabetes has not been stable and controlled for at least the past three months as defined by an HbA1C ≥ 10%
- Known drug or alcohol dependency within the past one year period
- Concomitant administration of medications known to affect blood pressure, except medications allowed by the protocol
- Night shift workers who routinely sleep during the daytime and whose work hours include midnight to 4:00 AM (ante meridian)
- Patients receiving any investigational therapy within one month of signing the informed consent form. Note that patients who have participated in previous MICARDIS (telmisartan) studies may participate in this study provided there has been at least one month between discontinuing the previous study and signing the consent for the present study
- Known hypersensitivity to any component of the formulations
- Any clinical condition which, in the opinion of the investigator would not allow safe completion of the protocol and safe administration of trial medication
About this study
Official title: A Prospective Randomized Open-Label, Blinded-Endpoint (PROBE) Trial Comparing MICARDIS® (Telmisartan) (80 mg QD) and Amlodipine (5 mg QD) in Patients With Mild-to-Moderate Hypertension Using Ambulatory Blood Pressure Monitoring.
The primary aim of the trial is the effect of telmisartan versus amlodipine in lowering ambulatory diastolic and/or systolic blood pressures in the last six hours of the dosing interval in patients with mild-to-moderate hypertension as measured by ambulatory blood pressure monitoring (ABPM)
- Conditions
- Hypertension
- Being tested
- Telmisartan, Amlodipine, Placebo
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelmisartanDrug
AmlodipineDevice
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Telmisartan | Experimental | 4-week placebo run-in, 8-week fixed dose period Receives: Drug: Telmisartan; Drug: Placebo |
| Amlodipine | Active comparator | 4-week placebo run-in, 8-week fixed dose period Receives: Device: Amlodipine; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline in diastolic and systolic blood pressure during the last six hours of a 24-hour dosing interval, measured by ambulatory blood pressure monitoring
Measured: Baseline (day 1), day 57 of the open-label period
Secondary outcomes (4)
Changes from baseline in diastolic and systolic blood pressure during other times during the 24-hour ABPM profile
Measured: Baseline (day 1), up to day 57 of the open-label period
Changes from baseline in seated trough diastolic and systolic blood pressures as measured by manual cuff
Measured: Baseline (day 27 of the single-blind period), days 1, 14, 28, 56 and 57 of the open-label period
Blood pressure responder rates based on ABPM
Measured: day 56 and 57 of the open-label period
Blood pressure responder rates based on manual cuff measurements
Measured: days 14, 28, 56 and 57 of the open-label period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2014 (estimated)
- Study startApr 1998
- Primary completionDec 1998
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- None (open label)
- Enrolment
- 431 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02177409
- Sponsor's protocol ID
- 502.258
- Status last verified
- Jul 2014
- First submitted
- 26 Jun 2014
- Last updated
- 8 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Open-Label, Blinded-Endpoint (PROBE) Trial Comparing MICARDIS® (Telmisartan) (80 mg QD) and Amlodipine (5 mg QD) in Patients With Mild-to-Moderate Hypertension Using Ambulatory Blood Pressure Monitoring.
- ClinicalTrials.gov ID
- NCT02177409
- Acronym / sponsor ID
- 502.258
- Conditions
- Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 431 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Apr 1998
- Primary completion
- Dec 1998 (actual)
- First posted
- 27 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary aim of the trial is the effect of telmisartan versus amlodipine in lowering ambulatory diastolic and/or systolic blood pressures in the last six hours of the dosing interval in patients with mild-to-moderate hypertension as measured by ambulatory blood pressure monitoring (ABPM)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telmisartan | Experimental | Drug: Telmisartan, Drug: Placebo4-week placebo run-in, 8-week fixed dose period |
| Amlodipine | Active comparator | Device: Amlodipine, Drug: Placebo4-week placebo run-in, 8-week fixed dose period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Mild-to-moderate hypertension defined as a mean seated diastolic blood pressure (BP) of ≥ 95 mm Hg and ≤ 114 mm Hg, measured by manual cuff sphygmomanometer, on the last visit (Visit 6) of the four-week placebo run-in period (baseline BP)
- Mean seated systolic blood pressure ≥ 140 mm Hg and ≤ 200 mm Hg, measured by manual cuff at Visit 6 (baseline BP)
- A 24-hour mean ABPM measurement of ≥ 130/85 mm Hg evaluated at Visit 7 (baseline ABPM)
- Age 18 or older
- Ability to provide written informed consent
Key exclusion criteria (28 listed)
- Pre-menopausal women (last menstruation ≤ 1 year prior to start of screening):
- Any women:
- Hepatic and/or renal dysfunction as defined by the following laboratory parameters
- At screening (Visit 1): clinically relevant sodium depletion, hyperkalemia, or hypokalemia
- Known or suspected secondary hypertension
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 | Drug | Telmisartan |
| Amlodipine | Device | Amlodipine |
| Placebo | Drug | Amlodipine, Telmisartan |
Primary outcome
Changes from baseline in diastolic and systolic blood pressure during the last six hours of a 24-hour dosing interval, measured by ambulatory blood pressure monitoring
Time frame: Baseline (day 1), day 57 of the open-label period
4 secondary outcomes
Changes from baseline in diastolic and systolic blood pressure during other times during the 24-hour ABPM profile
Time frame: Baseline (day 1), up to day 57 of the open-label period
Changes from baseline in seated trough diastolic and systolic blood pressures as measured by manual cuff
Time frame: Baseline (day 27 of the single-blind period), days 1, 14, 28, 56 and 57 of the open-label period
Blood pressure responder rates based on ABPM
Time frame: day 56 and 57 of the open-label period
Blood pressure responder rates based on manual cuff measurements
Time frame: days 14, 28, 56 and 57 of the open-label period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2014.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Telmisartan and Amlodipine in people with Hypertension, run by Boehringer Ingelheim.
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 5 inclusion and 28 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 8 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes from baseline in diastolic and systolic blood pressure during the last six hours of a 24-hour dosing interval, measured by ambulatory blood pressure monitoring (time frame: Baseline (day 1), day 57 of the open-label period). 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 8 Jul 2014.