An Observational Study to Evaluate the Efficacy of Lodoz in a Population of Hypertensive Patients (Lodoz OS)
|ClinicalTrials.gov Identifier: NCT01080742|
Recruitment Status : Completed
First Posted : March 4, 2010
Last Update Posted : August 5, 2014
|Condition or disease||Intervention/treatment|
|Hypertension||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.
|Study Type :||Observational|
|Actual Enrollment :||1007 participants|
|Official Title:||A Prospective Observational Study to Evaluate the Efficacy of Lodoz in a Population of Hypertensive Patients|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||June 2011|
|Actual Study Completion Date :||December 2011|
Drug: Lodoz (Combination of bisoprolol and hydrochlorothiazide)
- 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 ]
- Response rate for SBP (defined as ≥ 10 mm Hg or SBP < 140 mmHg) [ Time Frame: After 3 and 6 months of treatment ]
- Response rate for DBP (defined as ≥ 10 mm Hg or DBP < 90 mmHg) [ Time Frame: After 3 and 6 months of treatment ]
- Proportion of subjects having reached target BP level, regarding Thai Hypertension Society guideline [ Time Frame: After 3 and 6 months of treatment ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01080742
|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|