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

March 3, 2010
June 1, 2012
January 2010
June 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01080742 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
An Observational Study to Evaluate the Efficacy of Lodoz in a Population of Hypertensive Patients
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.

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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Residents of Thailand diagnosed with mild to moderate essential hypertension.

Hypertension
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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1007
December 2011
June 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Thailand
 
NCT01080742
EMR 200006-510
No
Merck KGaA
Merck KGaA
Not Provided
Principal Investigator: Dilok Piyayotai, MD Thammasat Heart Center, Thammasat University Hospital, 95 Moo 1, Klong Nueng, Klong Luang, Pathumthani 12120, Thailand
Merck KGaA
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP