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

Sponsor

Boehringer Ingelheim (Industry)

Overall Status

Completed

CT.gov ID

NCT02183701

Collaborator

(none)

715

Enrollment

Arms

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension	Drug: Telmisartan Drug: Losartan + Hydrochlorothiazide Drug: Placebo	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

715 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Apr 1, 1998

Actual Primary Completion Date :

Dec 1, 1998

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Telmisartan 4 weeks placebo run-in, 6-weeks fixed dose period	Drug: Telmisartan Drug: Placebo
Active Comparator: Losartan + Hydrochlorothiazide 4 weeks placebo run-in, 6-weeks fixed dose period (Losartan 50 mg / HCTZ 12.5 mg)	Drug: Losartan + Hydrochlorothiazide Drug: Placebo

Arm

Intervention/Treatment

Experimental: Telmisartan

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

Drug: Telmisartan

Drug: Placebo

Active Comparator: Losartan + Hydrochlorothiazide

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

Drug: Losartan + Hydrochlorothiazide

Drug: Placebo

Outcome Measures

Primary Outcome Measures

Change from baseline in 24-hour mean diastolic blood pressure measured by ABPM [Baseline (Day 28 of run-in period) and day 42]

Secondary Outcome Measures

Change from baseline in 24-hour mean systolic blood pressure measured by ABPM [Baseline (Day 28 of run-in period) and day 42]
Change from baseline in systolic and diastolic blood pressures during other time periods during the 24-hour ABPM profile [Baseline (Day 28 of run-in period) and day 42]
Change from baseline (Visit 2) in trough systolic and diastolic blood pressures measured by cuff sphygmomanometer [Baseline (Day 28 of run-in period) and day 42]
Number of patient with of adverse events [up to 10 weeks]
Changes from baseline in pulse rate [Baseline (Day 28 of run-in period) and day 42]
Changes in physical examination [Screening and day 43]
Changes in laboratory parameters [Screening and day 43]
Changes in 12-lead electrocardiogram (ECG) [Baseline (Day 29 of run-in period) and day 43]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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)