An Observational Study to Evaluate the Efficacy of Lodoz in a Population of Hypertensive Patients (Lodoz OS)
This is an observational, prospective, non-interventional, non-randomised, open label multicentric study planned to be conducted in 1000 subjects with mild to moderate primary hypertension in approximately 20 centres in Thailand. The purpose of this study is to examine the beneficial effects of combination of bisoprolol with hydrochlorothiazide available as Lodoz in treatment of Thai subjects with mild to moderate hypertension. The outcome of the study would also provide information on the optimal daily dosage schedule as well as adherence of Lodoz.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||A Prospective Observational Study to Evaluate the Efficacy of Lodoz in a Population of Hypertensive Patients|
- Mean systolic blood pressure (SBP) reduction and mean diastolic blood pressure (DBP) reduction at month 3 and 6 from baseline [ Time Frame: Baseline and until 6 months of treatment ] [ Designated as safety issue: No ]
- Response rate for SBP (defined as ≥ 10 mm Hg or SBP < 140 mmHg) [ Time Frame: After 3 and 6 months of treatment ] [ Designated as safety issue: No ]
- Response rate for DBP (defined as ≥ 10 mm Hg or DBP < 90 mmHg) [ Time Frame: After 3 and 6 months of treatment ] [ Designated as safety issue: No ]
- Proportion of subjects having reached target BP level, regarding Thai Hypertension Society guideline [ Time Frame: After 3 and 6 months of treatment ] [ Designated as safety issue: No ]The target BP level according to Thai Hypertension Society guideline is less than 140/90 mm Hg and less than 130/80 mm Hg in those with chronic kidney disease.
|Study Start Date:||January 2010|
|Study Completion Date:||December 2011|
|Primary Completion Date:||June 2011 (Final data collection date for primary outcome measure)|
Drug: Lodoz (Combination of bisoprolol and hydrochlorothiazide)
Essential hypertension is a heterogenous multifactorial disease affecting large number of population. Monotherapy treatment in hypertension is often unable to achieve the desired blood pressure (BP) goals and subjects even remain at significant risk for developing cardiovascular disease. The use of combination therapy as first line treatment for hypertension provides a solution to the management problems related to hypertension. Among combination drugs, low dose combinations are useful tools in treating large segments of hypertensive subjects because of their several advantages, such as simplified dosage regimens, improve compliance and hypertensive control, decrease dose dependent side effects as well as reduce costs.
- To evaluate the efficacy of Lodoz therapy when used in routine clinical practice in subjects with mild to moderate essential hypertension.
- To evaluate the discontinuation rate of Lodoz therapy.
|Thammasat Heart Center, Thammasat University Hospital|
|Pathumthani, Thailand, 12120|
|Principal Investigator:||Dilok Piyayotai, MD||Thammasat Heart Center, Thammasat University Hospital, 95 Moo 1, Klong Nueng, Klong Luang, Pathumthani 12120, Thailand|