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

Completed

• Conditions: Hypertension

• Registration Number: NCT01080742
• Lead Sponsor: Merck KGaA, Darmstadt, Germany

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.

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-03-03
• Study First Submitted QC: 2010-03-03
• Study First Posted: 2010-03-04
• Primary Completion: 2011-06
• Study Completion: 2011-12
• Status Verified: 2012-06
• Last Update Submitted: 2014-08-04
• Last Update Posted: 2014-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1007

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Thammasat Heart Center, Thammasat University Hospital; 🇹🇭 Pathumthani, Thailand