Clinical trial NCT01080742: An Observational Study to Evaluate the Efficacy of Lodoz in a Population of Hypertensive Patients
Official title: A Prospective Observational Study to Evaluate the Efficacy of Lodoz in a Population of Hypertensive Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Keywords: Hypertension
Lodoz
Bisoprolol
Hydrochlorothiazide
Lead sponsor: Merck KGaA, Darmstadt, Germany
Sponsor class: INDUSTRY
First posted: 2010-03-04
Enrollment: 1007
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Residents of Thailand diagnosed with mild to moderate essential hypertension.

Brief 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.

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 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

Primary outcomes:
measure: Mean systolic blood pressure (SBP) reduction and mean diastolic blood pressure (DBP) reduction at month 3 and 6 from baseline
timeFrame: Baseline and until 6 months of treatment
Secondary outcomes:
measure: Response rate for SBP (defined as ≥ 10 mm Hg or SBP < 140 mmHg)
timeFrame: After 3 and 6 months of treatment
measure: Response rate for DBP (defined as ≥ 10 mm Hg or DBP < 90 mmHg)
timeFrame: After 3 and 6 months of treatment
measure: Proportion of subjects having reached target BP level, regarding Thai Hypertension Society guideline
timeFrame: After 3 and 6 months of treatment
Other outcomes:
Locations:
city: Pathumthani
country: Thailand
facility: Thammasat Heart Center, Thammasat University Hospital
Study officials:
affiliation: Thammasat Heart Center, Thammasat University Hospital, 95 Moo 1, Klong Nueng, Klong Luang, Pathumthani 12120, Thailand
name: Dilok Piyayotai, MD
role: PRINCIPAL_INVESTIGATOR
References: