NCT01080742

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,007 (actual)
• Sponsor: Merck KGaA, Darmstadt, Germany · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypertension

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2010-01-01
• Primary completion: 2011-06-01
• Completion: 2011-12-01
• First posted: 2010-03-04
• Last updated: 2014-08-05

Locations

1 site across 1 country: Thailand