HypertensionPhase 4NCT01190436
A 12-week, Multicentric Study to Evaluate the Safety and Efficacy of Bisoprolol in Filipino Hypertensive Subjects With Diabetes
A Phase 4 study testing Bisoprolol in people with Hypertension, run by Merck KGaA, Darmstadt, Germany at 1 site in Philippines.
Trial summary
The aim of this 12-week, multicenter, interventional, prospective, open-label and single-arm study is to evaluate the safety and efficacy of 5 milligram per day (mg/day) and 10 mg/day bisoprolol in Filipino hypertensive subjects with diabetes as monotherapy or as an add-on therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Bisoprolol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 sitePhilippines
- Study dates
- Dec 2009to Dec 2011
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Adult subjects with hypertension, either newly diagnosed or treated but currently uncontrolled as defined by Joint National Committee (JNC) 7 for subjects with Type 2 diabetes mellitus (T2DM) (that is, greater than or equal to [>=] 130/80 mmHg)
- Aged at least 18 years old
- Diagnosed with T2DM and already on anti-diabetic therapy, and with glycosylated hemoglobin of less than 7 percent
Who cannot join
- Subjects who were already on beta-blocker therapy at the time of recruitment
- Subjects with heart rate of at most 60 beats per minute (bpm) at rest
- Subjects with secondary hypertension, congenital heart disease, coronary artery disease, peripheral arterial disease or congestive heart failure in any stage
- Subjects with coronary conduction disorders (bundle branch block)
- Subjects with signs of definitive target organ damage consistent with World Health Organization (WHO) Stage III or with severe renal or hepatic disease
- Subjects who are pregnant or expect to be pregnant within the 24-week study period
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- Subjects on oral contraceptives
- Subjects with asthma or a history of asthma
- Subjects with documented severe renal disease
- Subjects on anti-neoplastic drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study on the Efficacy of Bisoprolol and Its Influence on Selected Biochemical Parameters in Filipino Hypertensive Patients With Diabetes
The aim of this 12-week, multicenter, interventional, prospective, open-label and single-arm study is to evaluate the safety and efficacy of 5 milligram per day (mg/day) and 10 mg/day bisoprolol in Filipino hypertensive subjects with diabetes as monotherapy or as an add-on therapy.
- Conditions
- Hypertension
- Being tested
- Bisoprolol
- Keywords
- Hypertension, Diabetes Mellitus, Bisoprolol
- Medical subject headings
- Hypertension, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BisoprololDrug
Also called Bisoprolol fumarate, Ziac
Bisoprolol will be administered at an initial dose of 5 milligram (mg) once daily for 2 weeks. If the blood pressure would be greater than or equal to 130/80 mmHg after 2 weeks, then dose will be adjusted to 10 mg once daily. Total duration of study treatment will be 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Bisoprolol | Experimental | Not described Receives: Drug: Bisoprolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at Week 12
The change in diastolic and systolic BP at Week 12 was calculated as diastolic and systolic BP at Week 12 minus diastolic and systolic BP at baseline, respectively.
Measured: Baseline, Week 12
Percentage of Participants With Controlled BP
Controlled BP was defined as BP less than 130/80 mmHg.
Measured: Week 12
Percentage of Participants With Response to Study Drug
Response to study drug was defined as lowering of systolic BP by at least 10 mmHg from baseline.
Measured: Week 12
Mean Change From Baseline in Heart Rate at Week 12
The change in heart rate at Week 12 was calculated as the heart rate at Week 12 minus heart rate at baseline.
Measured: Baseline, Week 12
Percentage of Participants With Decrease in Heart Rate by at Least 10 Bpm at Week 12
Measured: Week 12
Secondary outcomes (6)
Percentage of Participants With Increased Glycosylated Hemoglobin (HbA1c) at Week 12
HbA1c represents the percentage of glycosylated hemoglobin. Percentage of participants with increased HbA1c (greater than 0.5% from baseline) at Week 12 was reported.
Measured: Week 12
Mean Change From Baseline in HbA1c at Week 12
HbA1c represents the percentage of glycosylated hemoglobin. The change in HbA1c at Week 12 was calculated as HbA1c at Week 12 minus HbA1c at baseline.
Measured: Baseline, Week 12
Percentage of Participants With Increased Fasting Blood Sugar (FBS) at Week 12
Percentage of participants with increased FBS (greater than 16 milligram per deciliter [mg/dL] from baseline) at Week 12 was reported.
Measured: Week 12
Mean Change From Baseline in Fasting Blood Sugar (FBS) Level at Week 12
The change in FBS level at Week 12 was calculated as FBS level at Week 12 minus FBS level at baseline.
Measured: Baseline, Week 12
Mean Change From Baseline in Total Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL) Cholesterol and Triglyceride Level at Week 12
The change in total cholesterol, LDL cholesterol, HDL cholesterol and triglyceride level at Week 12 was calculated as total cholesterol, LDL cholesterol, HDL cholesterol and triglyceride level at Week 12 minus total cholesterol, LDL cholesterol, HDL cholesterol and triglyceride level at baseline, respectively.
Measured: Baseline, Week 12
Number of Participants With Adverse Events (AEs)
An adverse event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship.
Measured: Baseline up to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2010 (estimated)
- Study startDec 2009
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Inc., Philippines
- Responsible party
- Sponsor
- Investigators
- Medical Responsible, Study director, Merck Inc., Philippines
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01190436
- Sponsor's protocol ID
- 200006-512
- Status last verified
- Jan 2017
- First submitted
- 26 Aug 2010
- Last updated
- 30 Jan 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Efficacy of Bisoprolol and Its Influence on Selected Biochemical Parameters in Filipino Hypertensive Patients With Diabetes
- ClinicalTrials.gov ID
- NCT01190436
- Acronym / sponsor ID
- 200006-512
- Conditions
- Hypertension
- Keywords
- Hypertension, Diabetes Mellitus, Bisoprolol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
- Collaborators
- Merck Inc., Philippines
- Study start
- Dec 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 27 Aug 2010 (estimated)
- Results
- Posted 23 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this 12-week, multicenter, interventional, prospective, open-label and single-arm study is to evaluate the safety and efficacy of 5 milligram per day (mg/day) and 10 mg/day bisoprolol in Filipino hypertensive subjects with diabetes as monotherapy or as an add-on therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bisoprolol | Experimental | Drug: Bisoprolol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult subjects with hypertension, either newly diagnosed or treated but currently uncontrolled as defined by Joint National Committee (JNC) 7 for subjects with Type 2 diabetes mellitus (T2DM) (that is, greater than or equal to [>=] 130/80 mmHg)
- Aged at least 18 years old
- Diagnosed with T2DM and already on anti-diabetic therapy, and with glycosylated hemoglobin of less than 7 percent
Key exclusion criteria (10 listed)
- Subjects who were already on beta-blocker therapy at the time of recruitment
- Subjects with heart rate of at most 60 beats per minute (bpm) at rest
- Subjects with secondary hypertension, congenital heart disease, coronary artery disease, peripheral arterial disease or congestive heart failure in any stage
- Subjects with coronary conduction disorders (bundle branch block)
- Subjects with signs of definitive target organ damage consistent with World Health Organization (WHO) Stage III or with severe renal or hepatic disease
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 |
|---|---|---|
| BisoprololAlso: Bisoprolol fumarate, ZiacBisoprolol will be administered at an initial dose of 5 milligram (mg) once daily for 2 weeks. If the blood pressure would be greater than or equal to 130/80 mmHg after 2 weeks, then dose will be adjusted to 10 mg once daily. Total duration of study treatment will be 12 weeks. | Drug | Bisoprolol |
Primary outcome
Mean Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at Week 12
Time frame: Baseline, Week 12
The change in diastolic and systolic BP at Week 12 was calculated as diastolic and systolic BP at Week 12 minus diastolic and systolic BP at baseline, respectively.
Percentage of Participants With Controlled BP
Time frame: Week 12
Controlled BP was defined as BP less than 130/80 mmHg.
Percentage of Participants With Response to Study Drug
Time frame: Week 12
Response to study drug was defined as lowering of systolic BP by at least 10 mmHg from baseline.
Mean Change From Baseline in Heart Rate at Week 12
Time frame: Baseline, Week 12
The change in heart rate at Week 12 was calculated as the heart rate at Week 12 minus heart rate at baseline.
Percentage of Participants With Decrease in Heart Rate by at Least 10 Bpm at Week 12
Time frame: Week 12
6 secondary outcomes
Percentage of Participants With Increased Glycosylated Hemoglobin (HbA1c) at Week 12
Time frame: Week 12
Mean Change From Baseline in HbA1c at Week 12
Time frame: Baseline, Week 12
Percentage of Participants With Increased Fasting Blood Sugar (FBS) at Week 12
Time frame: Week 12
Mean Change From Baseline in Fasting Blood Sugar (FBS) Level at Week 12
Time frame: Baseline, Week 12
Mean Change From Baseline in Total Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL) Cholesterol and Triglyceride Level at Week 12
Time frame: Baseline, Week 12
Number of Participants With Adverse Events (AEs)
Time frame: Baseline up to Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Medical Responsible study director
Merck Inc., Philippines
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bisoprolol in people with Hypertension, run by Merck KGaA, Darmstadt, Germany at 1 site in Philippines.
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 3 inclusion and 10 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 30 Jan 2017. 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 Philippines. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at Week 12 (time frame: Baseline, Week 12). The study lists 5 primary outcomes in all. 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 30 Jan 2017; AzTrials last refreshed its copy on 30 Oct 2026.