Efficacy and Safety of the Angiotensin II Receptor Antagonist Micardis® (Telmisartan) or Hydrochlorothiazide in the Management of Patients With Isolated Systolic Hypertension (ISH) (ARAMIS)

July 7, 2014 updated by: Boehringer Ingelheim

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1039

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

31 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Pre-menopausal women (last menstruation ≤ 1 year prior to start of run-in period) who:

    1. are not surgically sterile; and/or
    2. are nursing
    3. 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

  • Hepatic and/or renal dysfunction as defined by the following laboratory parameters:

    1. Serum glutamic pyruvate transaminase (ALT) or serum glutamic oxaloacetic transaminase (AST) > than 2 times the upper limit of normal range
    2. 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:

    1. Fasting blood glucose less than 200 mg/dl (11.1 mmol/l)
    2. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Drug: Placebo
Active Comparator: Hydrochlorothiazide
Drug: Hydrochlorothiazide
Experimental: Low dose of Micardis®
Drug: Low dose of Micardis®
Experimental: Medium dose of Micardis®
Drug: Medium dose of Micardis®
Experimental: High dose of Micardis®
Drug: High dose of Micardis®

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change from baseline in seated systolic blood pressure at trough (24 hours post-dose)
Time Frame: after 6 weeks of treatment
after 6 weeks of treatment
Change from baseline in urine albumine excretion rate
Time Frame: after 6 weeks of treatment
after 6 weeks of treatment
Change from baseline in pulse wave velocity
Time Frame: after 6 weeks of treatment
after 6 weeks of treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Percentage of patients achieving a target fall in SBP
Time Frame: after 6 weeks of treatment
after 6 weeks of treatment
Changes in seated diastolic blood pressure (DBP)
Time Frame: up to 6 weeks
up to 6 weeks
Change from baseline in augmentation index
Time Frame: after 6 weeks of treatment
after 6 weeks of treatment
Incidence and intensity of adverse events
Time Frame: up to 6 weeks
up to 6 weeks
Number of patients with relevant changes from baseline in physical examination
Time Frame: baseline, week 6
baseline, week 6
Number of patients with relevant changes in Heart Rate (HR)
Time Frame: up to 6 weeks
up to 6 weeks
Number of patients with relevant changes in laboratory parameters
Time Frame: up to 6 weeks
up to 6 weeks
Number of patients with relevant changes in 12-lead electrocardiogram (ECG)
Time Frame: up to 6 weeks
up to 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 1999

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2000

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 25, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 25, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 26, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 8, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 7, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 502.254

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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