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

NCT02242812 | Terminated Phase 4

• 1 other identifier: 502.393
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief 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. As secondary objectives, the improvement in left ventricular systolic and diastolic function and blood pressure reduction were assessed

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

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

  based on LVM measurements by magnetic resonance imaging (MRI)

  Baseline, day 180

Secondary Outcomes (12)

• Number of patients with adverse events

  up to 6.5 months

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

  Baseline, day 180

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

  Baseline, day 180

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

  Baseline, day 180

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

  Baseline, day 180

Study Arms (2)

Telmisartan

EXPERIMENTAL

MICARDIS®

Drug: Telmisartan; Drug: Placebo

Metoprolol succinate

ACTIVE COMPARATOR

BELOC ZOK®

Drug: Metoprolol succinate; Drug: Placebo

Interventions

Telmisartan DRUG

Telmisartan

Metoprolol succinate DRUG

Metoprolol succinate

Placebo DRUG

Metoprolol succinate; Telmisartan

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:
• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Hypertension

Interventions

Telmisartan; Metoprolol

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Propanols; Amines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2014
• First Posted: September 17, 2014
• Study Start: September 1, 2003
• Primary Completion: October 1, 2004
• Last Updated: September 17, 2014

Record last verified: 2014-09