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

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

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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: Lodoz (Combination of bisoprolol and hydrochlorothiazide)

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 Type: Observational
• Enrollment (Actual): 1007

Contacts and Locations

Study Locations

• Thailand
  • Pathumthani, Thailand, 12120
    • Thammasat Heart Center, Thammasat University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Residents of Thailand diagnosed with mild to moderate essential hypertension.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
Response rate for SBP (defined as ≥ 10 mm Hg or SBP < 140 mmHg)		After 3 and 6 months of treatment
Response rate for DBP (defined as ≥ 10 mm Hg or DBP < 90 mmHg)		After 3 and 6 months of treatment
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

Collaborators and Investigators

• Sponsor: Merck KGaA, Darmstadt, Germany
• Investigators: Principal Investigator: Dilok Piyayotai, MD, Thammasat Heart Center, Thammasat University Hospital, 95 Moo 1, Klong Nueng, Klong Luang, Pathumthani 12120, Thailand

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: March 3, 2010
• First Submitted That Met QC Criteria: March 3, 2010
• First Posted (Estimate): March 4, 2010

Study Record Updates

• Last Update Posted (Estimate): August 5, 2014
• Last Update Submitted That Met QC Criteria: August 4, 2014
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: Hypertension; Bisoprolol; Hydrochlorothiazide; Lodoz
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Autonomic Agents; Peripheral Nervous System Agents; Natriuretic Agents; Membrane Transport Modulators; Diuretics; Sympatholytics; Adrenergic beta-1 Receptor Antagonists; Sodium Chloride Symporter Inhibitors; Bisoprolol; Hydrochlorothiazide
• Other Study ID Numbers: EMR 200006-510