HypertensionPhase 3ARAMISNCT02175355
Efficacy and Safety of the Angiotensin II Receptor Antagonist Micardis® (Telmisartan) or Hydrochlorothiazide in the Management of Patients With Isolated Systolic Hypertension (ISH)
A Phase 3 study testing Low dose of Micardis®, Medium dose of Micardis® and High dose of Micardis® in people with Hypertension, run by Boehringer Ingelheim.
Trial summary
Primary: To identify doses of Micardis®(telmisartan) which, administered once daily, are more effective than placebo and not inferior to HCTZ in lowering systolic blood pressure (SBP) in patients with isolated systolic hypertension (ISH), and to assess the dose response relationship of the antihypertensive effect of… Read more about this study
- Who is it for?
- Ages 35 to 84 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Low dose of Micardis®, Medium dose of Micardis® and High dose of Micardis®
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,039 participants
- Where
- No sites listed yet
- Study dates
- Oct 1999to Aug 2000
- 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 35 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 35 years, but less than 85 years of age
- Mean SBP ≥ 150 mm Hg and mean DBP < 90 mm Hg at the randomisation visit (visit 2), according to WHO definitions of ISH (excluding the subgroup of borderline ISH)
- Hypertensive patients not on current antihypertensive therapy or able to stop current treatment for a period of up to 8 - 10 weeks without endangering the health of the patient (investigator's discretion)
- Ability to provide written informed consent
Who cannot join
- Pre-menopausal women (last menstruation ≤ 1 year prior to start of run-in period) who:
- are not surgically sterile; and/or
- are nursing
- are of child-bearing potential and are not practicing acceptable means of birth control or do NOT plan to continue using this method throughout the study. Acceptable methods of birth control include oral, implantable or injectable contraceptives
- Mean systolic blood pressure ≥ 180 mmHg at the randomization Visit 2
- Known or suspected secondary hypertension
Show all 33Show fewer
- Hepatic and/or renal dysfunction as defined by the following laboratory parameters:
- Serum glutamic pyruvate transaminase (ALT) or serum glutamic oxaloacetic transaminase (AST) > than 2 times the upper limit of normal range
- Serum creatinine > or 1.8 mg/dl (or 159 µmol/l)
- Bilateral renal artery stenosis; renal artery stenosis in a solitary kidney, patients post-renal transplant or with only one functioning kidney
- Clinically relevant hypokalemia or hyperkalemia
- Uncorrected volume or sodium depletion
- Primary aldosteronism
- Hereditary fructose intolerance
- Biliary obstructive disorders
- Symptomatic congestive heart failure
- Angina pectoris or previous myocardial infarction
- Previous percutaneous transluminal coronary angioplasty or coronary artery bypass craft
- Previous cerebrovascular accident or hypertensive encephalopathy or transient ischemic attack(s)
- Current treatment with any antihypertensive agents, whether or not prescribed for this indication, that cannot be safely stopped (investigators decision) by the start of the run-in period. Any pre-treatment with diuretics, ACE inhibitors or angiotensin II receptor antagonists requires an extension of the run-in period from 2 to 4 weeks for adequate wash-out
- Atrial fibrillation (controlled or otherwise) or any other clinically relevant cardiac arrhythmias as determined by the clinical investigator
- Hemodynamically relevant aortic or mitral valve stenosis, obstructive hypertrophic cardiomyopathy or other outflow obstruction of the left ventricle
- Patients with non-insulin-dependent diabetes mellitus requiring treatment with oral hypoglycemics who fail to meet the following criteria by history:
- Fasting blood glucose less than 200 mg/dl (11.1 mmol/l)
- Therapy stabilized for at least one month prior to start of placebo run-period
- Patients with diabetes mellitus requiring treatment with insulin
- Patients who have previously experienced symptoms characteristics of angioedema during treatment with ACE inhibitors or angiotensin II receptor antagonists
- Known drug or alcohol dependency
- Any investigational therapy within one month of signing the informed consent form and during the trial
- Known hypersensitivity to any component of the formulation of telmisartan or hydrochlorothiazide including allergy to sulfonamides
- Concomitant use of lithium or cholestyramine or colestipol resins (potential drug interactions with HCTZ)
- Gout (contraindication for treatment with HCTZ)
- Any other clinical condition which, in the opinion of the principal investigator, would not allow safe completion of the protocol and safe administration of telmisartan or hydrochlorothiazide
About this study
Official title: A Randomised, Double- Blind, Placebo-controlled, 6 Week Parallel-group Trial on the Efficacy and Safety of the Angiotensin II Receptor Antagonist Micardis® (Telmisartan 20 mg, 40 mg or 80 mg, p.o. Once Daily) or Hydrochlorothiazide 12.5 mg p.o. Once Daily in the Management of Patients With Isolated Systolic Hypertension (ISH). (ARAMIS - Study = Angiotensin II Receptor Antagonist Micardis in Isolated Systolic Hypertension)
Primary: To identify doses of Micardis®(telmisartan) which, administered once daily, are more effective than placebo and not inferior to HCTZ in lowering systolic blood pressure (SBP) in patients with isolated systolic hypertension (ISH), and to assess the dose response relationship of the antihypertensive effect of telmisartan over the dose range of 20 to 80 mg.
Secondary: Target fall in SBP, change from baseline in seated DBP. Safety and tolerability of Micardis® and HCTZ in patients with ISH as measured by changes in physical examinations, heart rate, laboratory parameters and/or 12-lead ECG, as well as the incidence and severity of adverse events.
- Conditions
- Hypertension
- Being tested
- Low dose of Micardis®, Medium dose of Micardis®, High dose of Micardis®, 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.
Low dose of Micardis®Drug
Medium dose of Micardis®Drug
High dose of Micardis®Drug
HydrochlorothiazideDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Low dose of Micardis® | Experimental | Not described Receives: Drug: Low dose of Micardis® |
| Medium dose of Micardis® | Experimental | Not described Receives: Drug: Medium dose of Micardis® |
| High dose of Micardis® | Experimental | Not described Receives: Drug: High dose of Micardis® |
| Hydrochlorothiazide | Active comparator | Not described Receives: Drug: Hydrochlorothiazide |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in seated systolic blood pressure at trough (24 hours post-dose)
Measured: after 6 weeks of treatment
Change from baseline in urine albumine excretion rate
Measured: after 6 weeks of treatment
Change from baseline in pulse wave velocity
Measured: after 6 weeks of treatment
Secondary outcomes (8)
Percentage of patients achieving a target fall in SBP
Measured: after 6 weeks of treatment
Changes in seated diastolic blood pressure (DBP)
Measured: up to 6 weeks
Change from baseline in augmentation index
Measured: after 6 weeks of treatment
Incidence and intensity of adverse events
Measured: up to 6 weeks
Number of patients with relevant changes from baseline in physical examination
Measured: baseline, week 6
Number of patients with relevant changes in Heart Rate (HR)
Measured: up to 6 weeks
Number of patients with relevant changes in laboratory parameters
Measured: up to 6 weeks
Number of patients with relevant changes in 12-lead electrocardiogram (ECG)
Measured: up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2014 (estimated)
- Study startOct 1999
- Primary completionAug 2000
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
- Double blind
- Enrolment
- 1,039 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
- NCT02175355
- Sponsor's protocol ID
- 502.254
- Acronym
- ARAMIS
- Status last verified
- Jul 2014
- First submitted
- 25 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 Randomised, Double- Blind, Placebo-controlled, 6 Week Parallel-group Trial on the Efficacy and Safety of the Angiotensin II Receptor Antagonist Micardis® (Telmisartan 20 mg, 40 mg or 80 mg, p.o. Once Daily) or Hydrochlorothiazide 12.5 mg p.o. Once Daily in the Management of Patients With Isolated Systolic Hypertension (ISH). (ARAMIS - Study = Angiotensin II Receptor Antagonist Micardis in Isolated Systolic Hypertension)
- ClinicalTrials.gov ID
- NCT02175355
- Acronym / sponsor ID
- ARAMIS / 502.254
- Conditions
- Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,039 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Oct 1999
- Primary completion
- Aug 2000 (actual)
- First posted
- 26 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.
Primary: To identify doses of Micardis®(telmisartan) which, administered once daily, are more effective than placebo and not inferior to HCTZ in lowering systolic blood pressure (SBP) in patients with isolated systolic hypertension (ISH), and to assess the dose response relationship of the antihypertensive effect of telmisartan over the dose range of 20 to 80 mg.
Secondary: Target fall in SBP, change from baseline in seated DBP. Safety and tolerability of Micardis® and HCTZ in patients with ISH as measured by changes in physical examinations, heart rate, laboratory parameters and/or 12-lead ECG, as well as the incidence and severity of adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Low dose of Micardis® | Experimental | Drug: Low dose of Micardis® |
| Medium dose of Micardis® | Experimental | Drug: Medium dose of Micardis® |
| High dose of Micardis® | Experimental | Drug: High dose of Micardis® |
| Hydrochlorothiazide | Active comparator | Drug: Hydrochlorothiazide |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 35 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- At least 35 years, but less than 85 years of age
- Mean SBP ≥ 150 mm Hg and mean DBP < 90 mm Hg at the randomisation visit (visit 2), according to WHO definitions of ISH (excluding the subgroup of borderline ISH)
- Hypertensive patients not on current antihypertensive therapy or able to stop current treatment for a period of up to 8 - 10 weeks without endangering the health of the patient (investigator's discretion)
- Ability to provide written informed consent
Key exclusion criteria (33 listed)
- Pre-menopausal women (last menstruation ≤ 1 year prior to start of run-in period) who:
- Mean systolic blood pressure ≥ 180 mmHg at the randomization Visit 2
- Known or suspected secondary hypertension
- Hepatic and/or renal dysfunction as defined by the following laboratory parameters:
- Bilateral renal artery stenosis; renal artery stenosis in a solitary kidney, patients post-renal transplant or with only one functioning kidney
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 |
|---|---|---|
| Low dose of Micardis® | Drug | Low dose of Micardis® |
| Medium dose of Micardis® | Drug | Medium dose of Micardis® |
| High dose of Micardis® | Drug | High dose of Micardis® |
| Hydrochlorothiazide | Drug | Hydrochlorothiazide |
| Placebo | Drug | Placebo |
Primary outcome
Change from baseline in seated systolic blood pressure at trough (24 hours post-dose)
Time frame: after 6 weeks of treatment
Change from baseline in urine albumine excretion rate
Time frame: after 6 weeks of treatment
Change from baseline in pulse wave velocity
Time frame: after 6 weeks of treatment
8 secondary outcomes
Percentage of patients achieving a target fall in SBP
Time frame: after 6 weeks of treatment
Changes in seated diastolic blood pressure (DBP)
Time frame: up to 6 weeks
Change from baseline in augmentation index
Time frame: after 6 weeks of treatment
Incidence and intensity of adverse events
Time frame: up to 6 weeks
Number of patients with relevant changes from baseline in physical examination
Time frame: baseline, week 6
Number of patients with relevant changes in Heart Rate (HR)
Time frame: up to 6 weeks
Number of patients with relevant changes in laboratory parameters
Time frame: up to 6 weeks
Number of patients with relevant changes in 12-lead electrocardiogram (ECG)
Time frame: up to 6 weeks
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.
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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 Low dose of Micardis®, Medium dose of Micardis® and High dose of Micardis® 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 4 inclusion and 33 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. Some participants in this study may receive a placebo. 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?
Change from baseline in seated systolic blood pressure at trough (24 hours post-dose) (time frame: after 6 weeks of treatment). The study lists 3 primary outcomes in all. 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.