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NCT Number: NCT01080742

An 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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Thammasat Heart Center, Thammasat University Hospital

Pathum Thani, 12120, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lodoz (Combination of bisoprolol and hydrochlorothiazide)

Drug

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 names: Lodoz

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Merck KGaA, Darmstadt, Germany

Industry

Registry information

Official study title

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

Acronym: Lodoz OS

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Mar 4, 2010
Registry last updated
Aug 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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