Open-label Follow-up Trial of Fixed Dose Combination of Telmisartan + Hydrochlorothiazide in Hypertensive Patients
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|ClinicalTrials.gov Identifier: NCT00267943|
Recruitment Status : Completed
First Posted : December 22, 2005
Last Update Posted : November 13, 2013
|Condition or disease||Intervention/treatment||Phase|
|Hypertension||Drug: telmisartan 80 mg + hydrochlorothiazide 25 mg||Phase 3|
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.
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||639 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label Follow-up Trial of the Efficacy and Safety of Chronic Administration of the Fixed Dose Combination of Telmisartan 80 mg + Hydrochlorothiazide 25 mg Tablets Alone or in Combination With Other Antihypertensive Medications in Patients With Hypertension.|
|Study Start Date :||January 2006|
|Primary Completion Date :||January 2007|
|Estimated Study Completion Date :||January 2007|
- Proportion of patients achieving diastolic blood pressure (DBP) control 24 hours after last dose [ Time Frame: at 6 months ]
- Change from baseline in trough seated DBP. [ Time Frame: at 6 months ]
- Change from baseline in trough seated systolic blood pressure (SBP) [ Time Frame: at 6 months ]
- Proportion of patients achieving DBP response (trough seated DBP<90 mmHg or trough seated DBP reduction from baseline ≥10 mmHg) [ Time Frame: at 6 months ]
- Proportion of patients achieving SBP response (trough seated SBP<140 mmHg or trough seated SBP reduction from baseline ≥10 mmHg) [ Time Frame: at 6 months ]
- Proportion of patients achieving SBP response (trough seated SBP<140 mmHg or trough seated SBP reduction from baseline ≥20 mmHg) [ Time Frame: at 6 months ]
- Proportion of patients in the trough seated BP category optimal [ Time Frame: at 6 months ]
- Proportion of patients in the trough seated BP category normal [ Time Frame: at 6 months ]
- Proportion of patients in the trough seated BP category high-normal [ Time Frame: at 6 months ]
- Proportion of patients in the trough seated BP category high [ Time Frame: at 6 months ]
- Proportion of patients requiring additional antihypertensive therapy to achieve DBP control [ Time Frame: at 6 months ]
- Additional reduction in BP by the use of additional antihypertensive therapy [ Time Frame: at 6 months ]
- Time to starting additional antihypertensive therapy [ Time Frame: within 6 months ]
- Incidence and intensity of Adverse events [ Time Frame: 6 month ]
- Physical examinations [ Time Frame: 6 month ]
- Change in laboratory parameters [ Time Frame: 6 month ]
- 12-Lead Electrocardiogramm ECG [ Time Frame: 6 month ]
- Vital Signs (pulse rate, SBP, DBP) [ Time Frame: 6 month ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00267943
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|Study Chair:||Boehringer Ingelheim Study Coordinator||BIL UK / Ireland|