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Telmisartan Compared to Losartan + Hydrochlorothiazide in Patients With Mild-to-moderate Essential Hypertension

Primary Purpose

Hypertension

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Telmisartan
Losartan + Hydrochlorothiazide
Placebo
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Mild-to-moderate essential hypertension defined as a mean seated diastolic blood pressure measurement of ≥ 95 mmHg measured by manual cuff sphygmomanometer, on Visit 2 of the four-week placebo run-in period (baseline)
  • Mean seated systolic blood pressure ≥ 140 mmHg, measured by manual cuff at baseline (Visit 2)
  • A 24-hour mean diastolic blood pressure , measured by ABPM, of ≥ 85 mmHg evaluated at baseline (Visit 3)
  • Age 18 or older
  • Patient's written informed consent in accordance with GCP (Good Clinical Practice) and local legislation

Exclusion Criteria:

  • Pre-menopausal women (last menstruation ≤ 1 year prior to date of consent):

    • Who are not surgically sterile (hysterectomy, tubal ligation)
    • Who are NOT practising acceptable means of birth control or who do NOT plan to continue using an acceptable method throughout the trial. Acceptable methods of birth control include IUD (intrauterine device), oral, implantable or injectable contraceptives
    • Who have a positive urine pregnancy test
    • Who are nursing
  • Mean seated diastolic blood pressure (DBP) > 114 mmHg or mean seated systolic BP > 200 mmHg, by manual cuff
  • Any known hepatic and/or renal dysfunction as defined by the following laboratory parameters:

    • SGPT (serum glutamate pyruvate transaminase) (ALT) or SGOT (serum glutamate oxaloacetate transaminase) (AST) greater than two times the upper limit of normal
    • Serum creatinine > 1.8 mg/dl (or 159 µmol/l)
  • Clinically relevant hypokalemia
  • Known or suspected secondary hypertension
  • Known 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 3 months; stable angina where a change in nitrate therapy (dose or frequency) during the run-in period was required
  • Stroke within the past 6 months prior to start of run-in period
  • Myocardial infarction or cardiac surgery within the past 3 months prior to start of run-in period
  • PTCA (percutaneous transluminal coronary angioplasty) within the past 3 months prior to start of run-in period
  • Previous history of angioedema
  • Sustained ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant cardiac arrhythmias as determined by the investigator
  • Hypertrophic obstructive cardiomyopathy, hemodynamically relevant stenosis of the aortic or mitral valve
  • Patients with unstable insulin-dependent diabetes mellitus (risk of hypoglycemia or HbA1c ≥ 10 % in history within 6 months prior to start of run-in period)
  • Known drug or alcohol dependency within the past 6 months period prior to start of run-in period
  • Concomitant administration of medications known to affect blood pressure, except medications allowed by the protocol
  • Patients receiving any investigational therapy within one month of signing the informed consent form
  • 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
  • Concomitant use of lithium or cholestyramine or colestipol resins (potential drug interactions with HCTZ)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Telmisartan

    Losartan + Hydrochlorothiazide

    Arm Description

    4 weeks placebo run-in, 6-weeks fixed dose period

    4 weeks placebo run-in, 6-weeks fixed dose period (Losartan 50 mg / HCTZ 12.5 mg)

    Outcomes

    Primary Outcome Measures

    Change from baseline in 24-hour mean diastolic blood pressure measured by ABPM

    Secondary Outcome Measures

    Change from baseline in 24-hour mean systolic blood pressure measured by ABPM
    Change from baseline in systolic and diastolic blood pressures during other time periods during the 24-hour ABPM profile
    Change from baseline (Visit 2) in trough systolic and diastolic blood pressures measured by cuff sphygmomanometer
    Number of patient with of adverse events
    Changes from baseline in pulse rate
    Changes in physical examination
    Changes in laboratory parameters
    Changes in 12-lead electrocardiogram (ECG)

    Full Information

    First Posted
    July 7, 2014
    Last Updated
    July 7, 2014
    Sponsor
    Boehringer Ingelheim
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02183701
    Brief Title
    Telmisartan Compared to Losartan + Hydrochlorothiazide in Patients With Mild-to-moderate Essential Hypertension
    Official Title
    A Prospective Randomised Open-Label Blinded Endpoint Trial Comparing Telmisartan 80 mg and Losartan 50 mg + Hydrochlorothiazide 12.5 mg (Fixed Dose Combination) in Patients With Mild-to-Moderate Essential Hypertension Using Ambulatory Blood Pressure Monitoring
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    April 1998 (undefined)
    Primary Completion Date
    December 1998 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Boehringer Ingelheim

    4. Oversight

    5. Study Description

    Brief Summary
    The general aim and clinical objective of this trial is to determine the effect of telmisartan 80 mg compared to losartan 50 mg + HCTZ (Hydrochlorothiazide) 12.5 mg on reduction of blood pressure (BP) in patients with mild to moderate hypertension as assessed by 24 hour Ambulatory Blood Pressure Monitoring (ABPM) and trough sitting BP cuff measurements at the end of the treatment.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypertension

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    715 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Telmisartan
    Arm Type
    Experimental
    Arm Description
    4 weeks placebo run-in, 6-weeks fixed dose period
    Arm Title
    Losartan + Hydrochlorothiazide
    Arm Type
    Active Comparator
    Arm Description
    4 weeks placebo run-in, 6-weeks fixed dose period (Losartan 50 mg / HCTZ 12.5 mg)
    Intervention Type
    Drug
    Intervention Name(s)
    Telmisartan
    Intervention Type
    Drug
    Intervention Name(s)
    Losartan + Hydrochlorothiazide
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Primary Outcome Measure Information:
    Title
    Change from baseline in 24-hour mean diastolic blood pressure measured by ABPM
    Time Frame
    Baseline (Day 28 of run-in period) and day 42
    Secondary Outcome Measure Information:
    Title
    Change from baseline in 24-hour mean systolic blood pressure measured by ABPM
    Time Frame
    Baseline (Day 28 of run-in period) and day 42
    Title
    Change from baseline in systolic and diastolic blood pressures during other time periods during the 24-hour ABPM profile
    Time Frame
    Baseline (Day 28 of run-in period) and day 42
    Title
    Change from baseline (Visit 2) in trough systolic and diastolic blood pressures measured by cuff sphygmomanometer
    Time Frame
    Baseline (Day 28 of run-in period) and day 42
    Title
    Number of patient with of adverse events
    Time Frame
    up to 10 weeks
    Title
    Changes from baseline in pulse rate
    Time Frame
    Baseline (Day 28 of run-in period) and day 42
    Title
    Changes in physical examination
    Time Frame
    Screening and day 43
    Title
    Changes in laboratory parameters
    Time Frame
    Screening and day 43
    Title
    Changes in 12-lead electrocardiogram (ECG)
    Time Frame
    Baseline (Day 29 of run-in period) and day 43

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Mild-to-moderate essential hypertension defined as a mean seated diastolic blood pressure measurement of ≥ 95 mmHg measured by manual cuff sphygmomanometer, on Visit 2 of the four-week placebo run-in period (baseline) Mean seated systolic blood pressure ≥ 140 mmHg, measured by manual cuff at baseline (Visit 2) A 24-hour mean diastolic blood pressure , measured by ABPM, of ≥ 85 mmHg evaluated at baseline (Visit 3) Age 18 or older Patient's written informed consent in accordance with GCP (Good Clinical Practice) and local legislation Exclusion Criteria: Pre-menopausal women (last menstruation ≤ 1 year prior to date of consent): Who are not surgically sterile (hysterectomy, tubal ligation) Who are NOT practising acceptable means of birth control or who do NOT plan to continue using an acceptable method throughout the trial. Acceptable methods of birth control include IUD (intrauterine device), oral, implantable or injectable contraceptives Who have a positive urine pregnancy test Who are nursing Mean seated diastolic blood pressure (DBP) > 114 mmHg or mean seated systolic BP > 200 mmHg, by manual cuff Any known hepatic and/or renal dysfunction as defined by the following laboratory parameters: SGPT (serum glutamate pyruvate transaminase) (ALT) or SGOT (serum glutamate oxaloacetate transaminase) (AST) greater than two times the upper limit of normal Serum creatinine > 1.8 mg/dl (or 159 µmol/l) Clinically relevant hypokalemia Known or suspected secondary hypertension Known 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 3 months; stable angina where a change in nitrate therapy (dose or frequency) during the run-in period was required Stroke within the past 6 months prior to start of run-in period Myocardial infarction or cardiac surgery within the past 3 months prior to start of run-in period PTCA (percutaneous transluminal coronary angioplasty) within the past 3 months prior to start of run-in period Previous history of angioedema Sustained ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant cardiac arrhythmias as determined by the investigator Hypertrophic obstructive cardiomyopathy, hemodynamically relevant stenosis of the aortic or mitral valve Patients with unstable insulin-dependent diabetes mellitus (risk of hypoglycemia or HbA1c ≥ 10 % in history within 6 months prior to start of run-in period) Known drug or alcohol dependency within the past 6 months period prior to start of run-in period Concomitant administration of medications known to affect blood pressure, except medications allowed by the protocol Patients receiving any investigational therapy within one month of signing the informed consent form 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 Concomitant use of lithium or cholestyramine or colestipol resins (potential drug interactions with HCTZ)

    12. IPD Sharing Statement

    Links:
    URL
    http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/502/502.257_U99-1695.pdf
    Description
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    Telmisartan Compared to Losartan + Hydrochlorothiazide in Patients With Mild-to-moderate Essential Hypertension

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