HypertensionLodoz OSNCT01080742
An Observational Study to Evaluate the Efficacy of Lodoz in a Population of Hypertensive Patients
An observational study of Hypertension, run by Merck KGaA, Darmstadt, Germany at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Lodoz (Combination of bisoprolol and hydrochlorothiazide)
- How many people
- 1,007 participants
- Where
- 1 siteThailand
- Study dates
- Jan 2010to Dec 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Residents of Thailand diagnosed with mild to moderate essential hypertension.
Who may be able to join
- Signed written informed consent
- Subjects diagnosed with mild to moderate essential hypertension
- Subjects foreseen for Lodoz treatment for hypertension
- Age ≥ 18 years
Who cannot join
- Subjects treated with Lodoz before study initiation
- Subjects who are pregnant
- Subjects with any known contraindications to Lodoz based on local label
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Thammasat Heart Center, Thammasat University Hospital
Pathum Thani, 12120
About this study
Official title: 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.
Read the 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.
- Conditions
- Hypertension
- Being tested
- Lodoz (Combination of bisoprolol and hydrochlorothiazide)
- Keywords
- Hypertension, Lodoz, Bisoprolol, Hydrochlorothiazide
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lodoz (Combination of bisoprolol and hydrochlorothiazide)Drug
Also called Lodoz
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean systolic blood pressure (SBP) reduction and mean diastolic blood pressure (DBP) reduction at month 3 and 6 from baseline
Measured: Baseline and until 6 months of treatment
Secondary outcomes (3)
Response rate for SBP (defined as ≥ 10 mm Hg or SBP < 140 mmHg)
Measured: After 3 and 6 months of treatment
Response rate for DBP (defined as ≥ 10 mm Hg or DBP < 90 mmHg)
Measured: After 3 and 6 months of treatment
Proportion of subjects having reached target BP level, regarding Thai Hypertension Society guideline
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.
Measured: After 3 and 6 months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2010 (estimated)
- Study startJan 2010
- Primary completionJun 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,007 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dilok Piyayotai, MD, Principal investigator, Thammasat Heart Center, Thammasat University Hospital, 95 Moo 1, Klong Nueng, Klong Luang, Pathumthani 12120, Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01080742
- Sponsor's protocol ID
- EMR 200006-510
- Acronym
- Lodoz OS
- Status last verified
- Jun 2012
- First submitted
- 3 Mar 2010
- Last updated
- 5 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study to Evaluate the Efficacy of Lodoz in a Population of Hypertensive Patients
- ClinicalTrials.gov ID
- NCT01080742
- Acronym / sponsor ID
- Lodoz OS / EMR 200006-510
- Conditions
- Hypertension
- Keywords
- Hypertension, Lodoz, Bisoprolol, Hydrochlorothiazide
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,007 participants (actual)
- Lead sponsor
- Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 4 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Residents of Thailand diagnosed with mild to moderate essential hypertension.
Key inclusion criteria (4 listed)
- Signed written informed consent
- Subjects diagnosed with mild to moderate essential hypertension
- Subjects foreseen for Lodoz treatment for hypertension
- Age ≥ 18 years
Key exclusion criteria (3 listed)
- Subjects treated with Lodoz before study initiation
- Subjects who are pregnant
- Subjects with any known contraindications to Lodoz based on local label
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lodoz (Combination of bisoprolol and hydrochlorothiazide)Also: LodozThe 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. | Drug | – |
Primary outcome
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
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dilok Piyayotai, MD principal investigator
Thammasat Heart Center, Thammasat University Hospital, 95 Moo 1, Klong Nueng, Klong Luang, Pathumthani 12120, Thailand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, run by Merck KGaA, Darmstadt, Germany at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2014.