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

Hypertension Clinical Trial

— Lodoz OS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01080742
• Other study ID #: EMR 200006-510
• Status: Completed
• Phase: N/A
• First received: March 3, 2010
• Last updated: August 4, 2014
• Start date: January 2010
• Est. completion date: December 2011

Study information

• Verified date: June 2012
• Source: Merck KGaA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ministry of Public Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1007
• Est. completion date: December 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hypertension

Intervention

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.

Locations

Country	Name	City	State
Thailand	Thammasat Heart Center, Thammasat University Hospital	Pathumthani

Sponsors (1)

Lead Sponsor	Collaborator
Merck KGaA

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Response rate for SBP (defined as = 10 mm Hg or SBP < 140 mmHg)		After 3 and 6 months of treatment	No
Secondary	Response rate for DBP (defined as = 10 mm Hg or DBP < 90 mmHg)		After 3 and 6 months of treatment	No
Secondary	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	No