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

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ClinicalTrials.gov Identifier: NCT01080742
Recruitment Status : Completed
First Posted : March 4, 2010
Last Update Posted : August 5, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Hypertension 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 Design

Study Type : Observational
Actual Enrollment : 1007 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Observational Study to Evaluate the Efficacy of Lodoz in a Population of Hypertensive Patients
Study Start Date : January 2010
Primary Completion Date : June 2011
Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. Response rate for SBP (defined as ≥ 10 mm Hg or SBP < 140 mmHg) [ Time Frame: After 3 and 6 months of treatment ]
  2. Response rate for DBP (defined as ≥ 10 mm Hg or DBP < 90 mmHg) [ Time Frame: After 3 and 6 months of treatment ]
  3. 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.


Eligibility Criteria

Information from the National Library of Medicine

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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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01080742


Locations
Thailand
Thammasat Heart Center, Thammasat University Hospital
Pathumthani, Thailand, 12120
Sponsors and Collaborators
Merck KGaA
Investigators
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
ClinicalTrials.gov Identifier: NCT01080742     History of Changes
Other Study ID Numbers: EMR 200006-510
First Posted: March 4, 2010    Key Record Dates
Last Update Posted: August 5, 2014
Last Verified: June 2012

Keywords provided by Merck KGaA:
Hypertension
Lodoz
Bisoprolol
Hydrochlorothiazide

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Hydrochlorothiazide
Bisoprolol
Antihypertensive Agents
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents