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

This study has been completed.
Information provided by (Responsible Party):
Merck KGaA Identifier:
First received: March 3, 2010
Last updated: August 4, 2014
Last verified: June 2012
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.

Condition Intervention
Drug: Lodoz (Combination of bisoprolol and hydrochlorothiazide)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Observational Study to Evaluate the Efficacy of Lodoz in a Population of Hypertensive Patients

Resource links provided by NLM:

Further study details as provided by Merck KGaA:

Primary Outcome Measures:
  • Mean systolic blood pressure (SBP) reduction and mean diastolic blood pressure (DBP) reduction at month 3 and 6 from baseline [ Time Frame: Baseline and until 6 months of treatment ]

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

Enrollment: 1007
Study Start Date: January 2010
Study Completion Date: December 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
    Other Name: 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.


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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Residents of Thailand diagnosed with mild to moderate essential hypertension.

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01080742

Thammasat Heart Center, Thammasat University Hospital
Pathumthani, Thailand, 12120
Sponsors and Collaborators
Merck KGaA
Principal Investigator: Dilok Piyayotai, MD Thammasat Heart Center, Thammasat University Hospital, 95 Moo 1, Klong Nueng, Klong Luang, Pathumthani 12120, Thailand
  More Information

Responsible Party: Merck KGaA Identifier: NCT01080742     History of Changes
Other Study ID Numbers: EMR 200006-510
Study First Received: March 3, 2010
Last Updated: August 4, 2014

Keywords provided by Merck KGaA:

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators processed this record on May 25, 2017