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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.
Sponsor:
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01080742
First received: March 3, 2010
Last updated: June 1, 2012
Last verified: June 2012
History of Changes
  Purpose

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
Hypertension
 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • Response rate for DBP (defined as ≥ 10 mm Hg or DBP < 90 mmHg) [ Time Frame: After 3 and 6 months of treatment ] [ Designated as safety issue: No ]
  • Proportion of subjects having reached target BP level, regarding Thai Hypertension Society guideline [ Time Frame: After 3 and 6 months of treatment ] [ Designated as safety issue: No ]
    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.

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT01080742     History of Changes
Other Study ID Numbers: EMR 200006-510
Study First Received: March 3, 2010
Last Updated: June 1, 2012
Health Authority: Thailand: Ministry of Public Health

Keywords provided by Merck KGaA:
Hypertension
Lodoz
Bisoprolol
Hydrochlorothiazide

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

ClinicalTrials.gov processed this record on May 19, 2013