An Observational Study to Evaluate the Efficacy of Lodoz in a Population of Hypertensive Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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. OBJECTIVES Primary objective: To evaluate the efficacy of Lodoz therapy when used in routine clinical practice in subjects with mild to moderate essential hypertension. Secondary objective: To evaluate the discontinuation rate of Lodoz therapy.

Official Title
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A Prospective Observational Study to Evaluate the Efficacy of Lodoz in a Population of Hypertensive Patients

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Lodoz (Combination of bisoprolol and hydrochlorothiazide)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed written informed consent Subjects diagnosed with mild to moderate essential hypertension Subjects foreseen for Lodoz treatment for hypertension Age ≥ 18 years Exclusion Criteria: Subjects treated with Lodoz before study initiation Subjects who are pregnant Subjects with any known contraindications to Lodoz based on local label

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Lodoz (Combination of bisoprolol and hydrochlorothiazide)|The investigator will decide in advance the best therapeutic strategy for each subject according to current practice, regardless of the potential participation of this subject in the study.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean systolic blood pressure (SBP) reduction and mean diastolic blood pressure (DBP) reduction at month 3 and 6 from baseline |  | Baseline and until 6 months of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate for SBP (defined as ≥ 10 mm Hg or SBP < 140 mmHg) |  | After 3 and 6 months of treatment | 
| Response rate for DBP (defined as ≥ 10 mm Hg or DBP < 90 mmHg) |  | After 3 and 6 months of treatment | 
| Proportion of subjects having reached target BP level, regarding Thai Hypertension Society guideline | 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. | After 3 and 6 months of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension, Lodoz, Bisoprolol, Hydrochlorothiazide