Open-label Follow-up Trial of Fixed Dose Combination of Telmisartan + Hydrochlorothiazide in Hypertensive Patients
- Conditions
- Hypertension
- Registration Number
- NCT00267943
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The primary objective is to assess the efficacy and safety of the fixed dose combination of telmisartan 80 mg + hydrochlorothiazide 25 mg (T80/H25) alone or in addition to other antihypertensive therapies during open-label, long-term treatment.
- Detailed Description
Patients with a history of hypertension who completed a preceding trial (number 502.480) within the previous fourteen (14) days will be considered for entry to this long-term open-label trial. All patients will receive 'T80/H25'. Additional antihypertensive therapy will be allowed if the patients' blood pressure is not well controlled. \[In the preceding double-blind trial 502.480, patients who failed to respond to the fixed dose combination of telmisartan 80 mg '+' hydrochlorothiazide 12.5 mg (T80/H12.5) were randomised to 'T80/H12.5' or T80H25 for eight weeks.\] This is a multi-centre, multinational trial with approximately 80 study centres participating. Only study centres participating in the preceding trial 502.480 can enter patients into this open-label trial. It is anticipated that a maximum of 480 patients will be entered into the trial in seventeen countries. Each trial centre is expected to enter between four and twenty-four patients.
Enrollment of patients into this trial will finish when the last patient completes the preceding trial 502.480. At this time, centres will be notified of the termination of recruitment and will not be authorized to include any further patients.
Patients will visit the clinic one month, three months and six months later for assessment of their blood pressure and general health. Their participation in the study is complete six months after the start of the treatment period.
Study Hypothesis:
No statistical hypothesis will be tested. Descriptive statistics will be used to characterise the effects of treatment with T80/H25 with and without other antihypertensive treatments.
Comparison(s):
The proportion of patients achieving DBP control will be summarised by the total number of patients in the trial as well as by the maximum achieved dose level according to the two categories of T80/H25 alone (T80/H25) and with other antihypertensive medication added (T80/H25/other). An additional sub-group summary by the treatment group in the preceding trial 502.480 (T80/H12.5 and T80/H25) will also be presented.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 639
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Proportion of patients achieving diastolic blood pressure (DBP) control 24 hours after last dose at 6 months
- Secondary Outcome Measures
Name Time Method Change from baseline in trough seated DBP. at 6 months Change from baseline in trough seated systolic blood pressure (SBP) at 6 months Proportion of patients achieving DBP response (trough seated DBP<90 mmHg or trough seated DBP reduction from baseline ≥10 mmHg) at 6 months Proportion of patients achieving SBP response (trough seated SBP<140 mmHg or trough seated SBP reduction from baseline ≥10 mmHg) at 6 months Proportion of patients in the trough seated BP category high-normal at 6 months Time to starting additional antihypertensive therapy within 6 months Incidence and intensity of Adverse events 6 month Physical examinations 6 month Change in laboratory parameters 6 month 12-Lead Electrocardiogramm ECG 6 month Vital Signs (pulse rate, SBP, DBP) 6 month Proportion of patients achieving SBP response (trough seated SBP<140 mmHg or trough seated SBP reduction from baseline ≥20 mmHg) at 6 months Proportion of patients in the trough seated BP category optimal at 6 months Proportion of patients in the trough seated BP category normal at 6 months Proportion of patients in the trough seated BP category high at 6 months Proportion of patients requiring additional antihypertensive therapy to achieve DBP control at 6 months Additional reduction in BP by the use of additional antihypertensive therapy at 6 months
Trial Locations
- Locations (16)
ALTI
🇫🇷Angers, France
Hopital Avicenne
🇫🇷Bobigny, France
C.A.P. Ronda Cerdanya
🇪🇸Mataro / Barcelona, Spain
Mg Recherches
🇫🇷Paris, France
Hospital Univ. Gregorio Mara?on
🇪🇸Madrid, Spain
Hospital de Galdakao
🇪🇸Galdakao / Vizcaya, Spain
Hospital de Mostoles - Medicina Interna
🇪🇸Mostoles / Madrid, Spain
C.A.P. Mosen Cinto Verdaguer
🇪🇸L'Hospitalet de Llobregat / Barcelona, Spain
Ospedale Arnaboldi
🇮🇹Broni (pv), Italy
Ospedale Civile
🇮🇹Vittorio Veneto (tv), Italy
Hospital del Conxo
🇪🇸Santiago de Compostela, Spain
Hospital Gral de Jerez de la Frontera
🇪🇸Jerez de la Frontera / Cadiz, Spain
IRCCS San Raffaele
🇮🇹Roma, Italy
Boehringer Ingelheim Investigational Site
🇨🇳Taipei, Taiwan
Hospital Municipal de Badalona
🇪🇸Badalona, Spain
Azienda Ospedaliera Universita di Ferrara
🇮🇹Ferrara, Italy