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HypertensionPhase 4NCT02242812

Telmisartan Effectiveness on Left Ventricular Mass Reduction (TELMAR) as Assessed by MRI, in Patients With Mild to Moderate Hypertension

A Phase 4 study testing Telmisartan and Metoprolol succinate in people with Hypertension, run by Boehringer Ingelheim.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The primary objective was to show that telmisartan is not inferior to metoprolol succinate in respect of the percentage change from baseline in LVMI(H) after a 6.5 months treatment period. 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 and Metoprolol succinate
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
24 participants
Where
No sites listed yet
Study dates
Sep 2003to Oct 2004
Phase
Phase 4
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Caucasian and non-Caucasian patients i.e. Asian patients with untreated essential hypertension as defined by either a mean systolic blood pressure (SBP) of >= 140 mm Hg or a mean diastolic blood pressure (DBP) of >= 90 mm Hg during normal daily activities (6:00 - 21:59 h) and/or a nocturnal (22:00 - 05:59 h) SBP mean of >= 120 mm Hg or a DBP mean of >= 70 mm Hg as measured by ABPM.
  • Presence of Left Ventricular Hypertrophy (LVH) as defined by MRI:
  • Caucasian patients: Left ventricular mass of > 0.8 g/cm for women or > 1.05 g/cm for men. Non-Caucasian i.e. Asian patients: Left ventricular mass of > 0.65 g/cm for women or > 0.85 g/cm for men
  • Age between 18 and 80 years
  • Written informed consent in accordance with Good Clinical Practice (GCP) guidelines and the local regulatory and legal requirements

Who cannot join

  • Contraindications to the class of drugs under study:
  • Contraindications against β Blocker or angiotensin receptor antagonists
  • A history of angioedema or known hypersensitivity to any component of the formulations
  • Contraindications on ethical grounds:
  • there are no specific contraindications ethical grounds foreseen in this study
  • General Contraindications:
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  • Pregnancy, lactation or child bearing potential (I.e. Pre-menopausal women (last menstruation < 1 year prior to start of run-in phase) who are not surgically sterile (hysterectomy, tubal ligation) or who are NOR practicing or do NOT plan to practice acceptable means of birth control (Intrauterine Device, oral implantable or injectable contraceptives) or who have a positive serum pregnancy test at screening or baseline)
  • Factors making follow up difficult (i.e. no fixed address)
  • Treatment with other investigational drugs within one month of signing informed consent
  • Clinically significant concomitant diseases:
  • Hepatic and/or renal dysfunction as defined by the following laboratory parameters:
  • Alanine amino transferase (SGPT (ALT)) or Aspartate amino transferase (SGOT (AST)) values above two times or Gamma glutaryl transferase (Gamma-GT) three times the upper normal limit
  • Serum creatinine > 150 mol/L
  • Clinically significant sodium or potassium depletion, clinically relevant hyperkalaemia
  • Uncorrected volume depletion
  • Primary aldosteronism
  • Hereditary fructose intolerance
  • Biliary obstructive disorders, cholestasis or moderate to severe hepatic insufficiency
  • Insulin-dependent diabetes mellitus
  • Congestive heart failure or ejection fraction < 35% New York Heart Association (NYHA) class III or IV
  • Unstable Angina
  • Sustained ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant cardiac arrhythmias as determined by the investigator
  • Post-renal transplant patients
  • Myocardial infarction or cardiac surgery within the preceding six months
  • Known drug or alcohol abuse within 6 months prior to start of study
  • Patients with MRI contraindications:
  • Implanted pacemaker or defibrillator
  • Implanted vascular clips
  • Gross obesity (i.e. patients weight > 150 kg)
  • Specific exclusion for the disease under study:
  • Known or suspected secondary hypertension
  • Known renal artery stenosis
  • Known endocrine disorders with secondary hypertension
  • Severe arterial hypertension as defined by a mean seated DBP > 115 mmHg or a mean seated SBP > 200 mmHg
  • Patients with a complete loss of diurnal BP variation, as defined by the lack of drop of BP during sleeping time or a drop of less than 5% when compared to daily mean BP
  • Hypertrophic obstructive cardiomyopathy, clinically relevant aortic valve stenosis or clinically relevant mitral valve disease; vascular disease affecting BP (coarctation; stenosis of A. subclavia)
  • Specific concomitant therapy exclusions:
  • Use of antihypertensive medication within the previous six months
  • Chronic administration of digoxin or other digitalis-type drugs, without regular monitoring of plasma level
  • Chronic administration of any medications known to affect blood pressure, except medications allowed by the protocol
  • Continuous (for more than two weeks) treatment within the last three months using at least on of the following drugs: β blockers, angiotensin converting enzyme inhibitors, angiotensin receptor blockers
  • Participation in another drug trial

About this study

Official title: Telmisartan Effectiveness on Left Ventricular MAss Reduction (TELMAR) as Assessed by MRI, in Patients With Mild to Moderate Hypertension - a Prospective, Randomised, Double-blind Comparison of Telmisartan 80 mg Oral, Once Daily, to Metoprolol Succinate 95 mg Oral, Once Daily, Over a Period of 6 Months

The primary objective was to show that telmisartan is not inferior to metoprolol succinate in respect of the percentage change from baseline in LVMI(H) after a 6.5 months treatment period. As secondary objectives, the improvement in left ventricular systolic and diastolic function and blood pressure reduction were assessed

Conditions
Hypertension
Being tested
Telmisartan, Metoprolol succinate, 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

  • Metoprolol succinateDrug

  • PlaceboDrug

Study groups in NCT02242812
Study groupRoleWhat they receive
TelmisartanExperimentalMICARDIS®
Receives: Drug: Telmisartan; Drug: Placebo
Metoprolol succinateActive comparatorBELOC ZOK®
Receives: Drug: Metoprolol succinate; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage change in left ventricular mass index relative to height (LVMI(H))

    based on LVM measurements by magnetic resonance imaging (MRI)

    Measured: Baseline, day 180

Secondary outcomes (12)

  1. Number of patients with adverse events

    Measured: up to 6.5 months

  2. Change of left ventricular mass index related to the body surface area (LVMI (BSA)) measured by MRI

    Measured: Baseline, day 180

  3. Change of left ventricular end-systolic (LVESV) measured by MRI

    Measured: Baseline, day 180

  4. Change of left ventricular end-diastolic volume (LVEDV) as measured by MRI

    Measured: Baseline, day 180

  5. Change of left ventricular end-diastolic volume index related to height LVEDVI (H))

    based on LV volumetric measurements by MRI

    Measured: Baseline, day 180

  6. Change of left ventricular end-diastolic volume index related to the body mass index (LVEDVI (BSA))

    based on LV volumetric measurements by MRI

    Measured: Baseline, day 180

  7. Change of left ventricular ejection fraction (EF)

    based on LV volumetric measurements by MRI

    Measured: Baseline, day 180

  8. Change of end-systolic wall stress (ESWS) measured by MRI

    Measured: Baseline, day 180

  9. Change of 24-hour mean systolic blood pressure measured by ambulatory blood pressure monitoring (ABPM)

    Measured: Baseline, day 179

  10. Change of 24-hour mean diastolic blood pressure as measure by ABPM

    Measured: Baseline, day 179

  11. Change of mean seated trough systolic blood pressure measured by manual cuff sphygmomanometer

    Measured: up to day 194

  12. Change of mean seated trough diastolic blood pressure measured by manual cuff sphygmomanometer

    Measured: up to day 194

Timeline

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

  1. First posted17 Sep 2014 (estimated)
  2. Study startSep 2003
  3. Primary completionOct 2004

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02242812
Sponsor's protocol ID
502.393
Status last verified
Sep 2014
First submitted
16 Sep 2014
Last updated
17 Sep 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Telmisartan and Metoprolol succinate 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 42 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: stopped early, as of the sponsor's last update on 17 Sep 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 was stopped early. Results are not available in the source record.

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?

Percentage change in left ventricular mass index relative to height (LVMI(H)) (time frame: Baseline, day 180). 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 NCT02242812.

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 17 Sep 2014.

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