An Observational Study to Evaluate the Efficacy of Lodoz in a Population of Hypertensive Patients
Information source: Merck KGaA
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: Lodoz (Combination of bisoprolol and hydrochlorothiazide) (Drug)
Phase: N/A
Status: Completed
Sponsored by: Merck KGaA Official(s) and/or principal investigator(s): Dilok Piyayotai, MD, Principal Investigator, Affiliation: Thammasat Heart Center, Thammasat University Hospital, 95 Moo 1, Klong Nueng, Klong Luang, Pathumthani 12120, Thailand
Summary
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.
Clinical Details
Official title: A Prospective Observational Study to Evaluate the Efficacy of Lodoz in a Population of Hypertensive Patients
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: Mean systolic blood pressure (SBP) reduction and mean diastolic blood pressure (DBP) reduction at month 3 and 6 from baseline
Secondary outcome: Response rate for SBP (defined as ≥ 10 mm Hg or SBP < 140 mmHg)Response rate for DBP (defined as ≥ 10 mm Hg or DBP < 90 mmHg) Proportion of subjects having reached target BP level, regarding Thai Hypertension Society guideline
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Thammasat Heart Center, Thammasat University Hospital, Pathumthani 12120, Thailand
Additional Information
Starting date: January 2010
Last updated: August 4, 2014
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