Hypertension
Conditions
Brief summary
Study to assess the efficacy of telmisartan 40-80 mg once daily compared with losartan 50-100 mg once daily in hypertensive patients evaluated by change from baseline in diastolic blood pressure (DBP) during the last 6 hours of the 24-hour dosing interval, at the end of the 12 weeks period of monotherapy treatment (ABPM - ambulatory blood pressure measurement). Secondary objectives: Changes from baseline in BP at the end of the monotherapy period of treatment and at the end of the study, evaluated by sphygmomanometric blood pressure measurement and ABPM Safety: Incidence of adverse events (AE's); withdrawal due to adverse events; laboratory parameters
Interventions
DRUGTelmisartan
DRUGLosartan
DRUGHydrochlorothiazide
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * Mild-to-moderate essential hypertension defined as a mean diastolic blood pressure (DBP) ≥ 95 mmHg and \< 110 mmHg and systolic blood pressure (SBP) \< 180 mmHg measured by manual cuff sphygmomanometer at the end of the wash-out period * Written informed consent
Exclusion criteria
* Nursing, pregnancy or childbearing potential women, post-menopausal women will be enrolled with last menstruation \> 1 year prior to start wash-out phase or surgically sterile * Secondary hypertension * Malignant hypertension (retinal haemorrhage, exudates or papillary oedema) * Clinically significant sodium depletion as defined by serum sodium level \< 130 mEq/L and/or clinically significant hyperkaliemia as defined by serum potassium level \> 5.5 mEq/L or clinically significant hypokaliemia as defined by serum potassium level \< 3.0 mEq/L * Atrial fibrillation or frequent ventricular ectopic beats or other arrhythmias which, in the investigator opinion could compromise patient's participation to the trial * Congestive heart failure (CHF) (NYHA (New York Heart Association) functional class CHF III-IV) * Angina pectoris or myocardial infarction * Cardiac surgery within the past 3 months prior to start the wash-out period * Stroke within the past 6 months prior to start the wash-out period * Renal insufficiency defined as creatininaemia \> 2mg/dl * Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post renal transplant, presence of only one functioning kidney * Liver insufficiency, defined as bilirubinaemia \> 2mg/dl and AST (aspartate aminotransferase) or ALT (alanine-aminotransferase) \> twice the upper normal range * Clinically significant metabolic and endocrine disease * Autoimmune disease * Previous history of angioedema * Body mass index \> 30kg/m2 * Arm circumference \> 32 cm * Any condition that may be likely to compromise patients participation to the trial (alcohol or drug abuse, disability illness, etc.) * Concomitant therapy with antihypertensive drugs non permitted by protocol, corticosteroids or drugs known to affect blood pressure * Concomitant use of lithium or cholestyramine or colestipol resins (potential drug interactions with HCTZ) * Investigational drug treatment within the past 30 days before the enrolment or concurrent participation to any other trial * Sensitivity, significant adverse reaction or contraindications to the study drugs (telmisartan, losartan, HCTZ) * Predictable lack of patient co-operation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in diastolic blood pressure (DBP) during the last 6 hours (ABPM - ambulatory blood pressure measurement) of the 24-hour dosing interval at the end of the monotherapy period of treatment | Baseline and week 12 |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in systolic blood pressure (SBP) during the last 6 hours (ABPM) of the 24-hour dosing interval | Baseline, week 12 and 24 |
| Change from baseline in DBP/SBP during the last 2 hours (ABPM) of the 24-hour dosing interval (trough BP) | Baseline, week 12 and 24 |
| Changes from baseline in trough cuff (sphygmomanometer) SBP/DBP | Baseline, week 12 and 24 |
| Changes from baseline in SBP/DBP of 24 hours mean ABPM | Baseline, week 12 and 24 |
| Comparison of SBP/DBP ABPM tracing profile | Week 12 and 24 |
| Change from baseline in DBP during the last 6 hours (ABPM) of the 24-hour dosing interval at the end of the study | Baseline and week 24 |
| Number of responders | Week 12 and 24 |
| Number of controlled responders | Week 12 and 24 |
| Number of patients who withdraw due to lack of efficacy | 24 weeks |
| Number of patients with adverse events | 24 weeks |
| Number of patients who withdraw due to adverse events | 24 weeks |
| Smoothness index in comparison with baseline | Baseline, week 12 and 24 |
Outcome results
None listed