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
About this trial
This is an interventional treatment trial for Hypertension
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)
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
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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