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Comparison of Bisoprolol With Metoprolol Succinate Sustained-release on Heart Rate and Blood Pressure in Hypertensive Patients (CREATIVE)

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ClinicalTrials.gov Identifier: NCT01508325

Recruitment Status : Completed First Posted : January xi, 2012 Results First Posted : May 13, 2015 Last Update Posted : May 13, 2015

Sponsor:

Collaborator:

Information provided by (Responsible Political party):

Merck KGaA, Darmstadt, Germany

Brief Summary:

This is a multicentre, randomized, open-characterization parallel trial to demonstrate the superiority and/or non-inferiority of bisoprolol on metoprolol succinate sustained-release (SR) tablet in subjects with mild to moderate primary hypertension.

Condition or illness	Intervention/treatment	Phase
Hypertension	Drug: Bisoprolol Drug: Metoprolol	Stage 4

Detailed Description:

Primary objectives:

To demonstrate that bisoprolol is superior in mean convalescent middle rate and/or not-inferior in mean ambulatory DBP equally compared with metoprolol SR in the last 4 hours later on 12-week active treatment in subjects with balmy to moderate essential hypertension (EH).

Secondary objectives:

1. To compare the efficacy of the 2 study drugs by 24h ambulatory monitoring by several parameters at unlike times (Example: blood force per unit area, heart charge per unit, their variability, etc...) subsequently 12-calendar week treatment from baseline among subjects with mild to moderate EH
2. To evaluate safety of the ii drugs
3. To evaluate the treatment compliance of the two drugs

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Study Type :	Interventional  (Clinical Trial)
Bodily Enrollment :	186 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Supportive Care
Official Title:	Comparing of Bisoprolol With Metoprolol Succinate Sustained-release on Heart Rate and Blood Pressure in Hypertensive Patients (CREATIVE Written report)
Written report Starting time Date :	December 2011
Actual Chief Completion Date :	April 2014
Actual Study Completion Appointment :	April 2014

Resource links provided by the National Library of Medicine

Arm	Intervention/treatment
Experimental: Bisoprolol	Drug: Bisoprolol Subjects volition receive bisoprolol fumarate (Concor®) at a dose of 5 milligram (mg) once daily orally as sustained release (SR) tablets for a period of 4 weeks. The dose of bisoprolol will exist escalated to 7.5 mg orally one time daily for next four weeks (Weeks four to 8) and to 10 mg orally once daily for the next iv weeks (Weeks 8 to 12), if clinic systolic blood force per unit area (SBP) was greater than or equal to (>=) 140 millimeters of mercury (mmHg) and/or diastolic claret pressure (DBP) was >=ninety mmHg measured every four weeks. Other Name: Concor
Agile Comparator: Metoprolol	Drug: Metoprolol Subjects will receive metoprolol succinate (Betaloc SR) at a dose of 47.5 mg once daily orally every bit SR tablets for a period of iv weeks. The dose of metoprolol will be escalated to 71.25 mg orally once daily for next 4 weeks (Weeks iv to 8) and to 95 mg orally one time daily for the next 4 weeks (Weeks viii to 12) if clinic SBP was >=140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks. Other Name: Betaloc SR

Main Outcome Measures :

1. Alter From Baseline in Mean Convalescent Diastolic Blood Force per unit area (DBP) in the Concluding 4 Hours After 12-week Treatment [ Time Frame: Baseline and Week 12 ]

   Ambulatory claret pressure monitoring (ABPM) determined blood pressure 3 times hourly in the daytime and once hourly in the dark. Only monitoring data with valid data greater than or equal to (>=) 80 pct (%) was used for analysis. Each ABPM lasted for at least 24 hours. The first dynamic claret pressure monitoring was used every bit baseline. The departure between the hateful ambulatory DBP observed in the concluding 4 hours afterwards 12-week handling and baseline was calculated to observe out the modify of mean ambulatory DBP at the terminate of the treatment.

   
   
2. Change From Baseline in Mean Heart Rate in the Last four Hours After 12-calendar week Treatment [ Time Frame: Baseline and Week 12 ]

   Pulse charge per unit was measured past palpation on radial artery for 1 infinitesimal. Two measurements were made at least 1 to 2 minutes apart. Finally mean heart rate was recorded. The offset measured heart rate was used as baseline heart rate. The deviation betwixt the concluding 4 hours center rate after 12-week handling and of the baseline centre rate was calculated to measure the change in hateful heart rate at the end of the treatment.

   
   

Secondary Issue Measures :

1. Change From Baseline in Mean Ambulatory Systolic Blood Pressure level (SBP) in the Terminal 4 Hours Later on 12-week Treatment [ Time Frame: Baseline and Week 12 ]

   The ABPM determined blood pressure 3 times hourly in the daytime and once hourly in the night. Only monitoring data with valid data >=80% was used for analysis. Each ABPM lasted for at least 24 hours. The first dynamic blood pressure level monitoring was used equally baseline. The difference between the mean ambulatory SBP observed in the concluding 4 hours later 12-week treatment and baseline was calculated to find out the change of mean ambulatory SBP at the cease of the handling.

   
   
2. Change From Baseline in Mean Ambulatory 24-hr Blood Pressure at Week 12 [ Time Frame: Baseline and Week 12 ]

   The ABPM determined claret pressure 3 times hourly in the daytime and once hourly in the night. Only monitoring information with valid data >=lxxx% was used for analysis. Each ABPM lasted for at least 24 hours. The offset dynamic claret force per unit area monitoring was used every bit baseline. The difference betwixt the mean ABPM observed in the last 24 hours at Calendar week 12 and baseline was calculated to find out the change of mean ABPM at the cease of the treatment.

   
   
3. Modify From Baseline in Mean Ambulatory Daytime Blood Pressure at Week 12 [ Time Frame: Baseline and Week 12 ]

   The ABPM determined blood pressure level 3 times hourly in the daytime. Only monitoring data with valid data >=lxxx% was used for assay. Each ABPM lasted for at least 24 hours. The first dynamic daytime blood pressure monitoring was used every bit baseline. The departure betwixt the mean ambulatory daytime blood pressure level observed at Calendar week 12 and baseline was calculated to find out the alter of mean ambulatory daytime claret pressure level at the terminate of the handling. Daytime in this study was defined as time betwixt 06:00 am to 10:00 pm.

   
   
4. Change From Baseline in Hateful Ambulatory Night-time Blood Pressure at Week 12 [ Time Frame: Baseline and Week 12 ]

   The ABPM determined claret pressure once hourly in the nighttime. Only monitoring information with valid information >=lxxx% was used for analysis. Each ABPM lasted for at least 24 hours. The offset dark blood pressure monitoring was used as baseline. The difference between the mean ambulatory nighttime blood pressure observed at Week 12 and baseline was calculated to find out the alter of mean ambulatory nighttime claret pressure at the end of the treatment. Nighttime in this study was defined as 10:00 pm to 06:00 am.

   
   
5. Change From Baseline in Mean Ambulatory Daytime Heart Rate at Week 12 [ Fourth dimension Frame: Baseline and Week 12 ]

   Pulse rate was measured by palpation on radial avenue for one minute. Two measurements were made at least 1 to two minutes apart. Finally hateful heart rate was recorded. The first measured daytime heart charge per unit was used as baseline heart rate. The deviation between the daytime heart rate at Calendar week 12 treatment and of the baseline middle rate was calculated to measure the change of mean ambulatory daytime heart rate at the end of the handling. Daytime in this study was defined as 06:00 am to 10:00 pm.

   
   
6. Change From Baseline in Mean Ambulatory Night-time Heart Rate at Week 12 [ Fourth dimension Frame: Baseline and Week 12 ]

   Pulse charge per unit was measured by palpation on radial artery for 1 minute. Two measurements were made at least 1 to 2 minutes autonomously. Finally mean center rate was recorded. The first measured eye rate was used as baseline middle charge per unit. The difference between the night center rate at Week 12 treatment and of the baseline middle charge per unit was calculated to measure the change of mean ambulatory nighttime center charge per unit at the end of the treatment. Nighttime was divers every bit 10:00 pm to 06:00 am.

   
   
7. Change From Baseline in 24-hr Blood Pressure Variability at Calendar week 12 [ Time Frame: Baseline and Week 12 ]

   The ABPM determined claret pressure 3 times hourly in the daytime and once hourly in the dark. But monitoring data with valid information >=80% was used for analysis. Each ABPM lasted for at least 24 hours. The first dynamic blood pressure level monitoring was used as baseline. The mean change in the blood pressure variability between the 24-hr blood pressure observed at Calendar week 12 and baseline was calculated.

   
   
8. Blood Pressure Response Rate [ Time Frame: Week 12 ]

   Claret pressure response was divers equally DBP less than or equal to (=<) 90 mmHg or >=10 mmHg decrease in DBP from baseline. Claret pressure level response rate was calculated as: number of subjects with blood pressure level response divided by total number of subjects and multiplied past 100.

   
   
9. Eye Rate Response Rate [ Time Frame: Week 12 ]

   Heart rate response was divers as decrease in heart rate from baseline >=10 percentage (%). Eye rate response charge per unit was calculated by using the number of subjects with heart charge per unit response divided by total number of subjects and multiplied by 100.

   
   
10. Change From Baseline in Hateful Ambulatory 24-60 minutes Heart Rate at Week 12 [ Time Frame: Baseline and Calendar week 12 ]

    Pulse charge per unit was measured by palpation on radial avenue for 1 infinitesimal. Two measurements were made at least 1 to two minutes apart. Finally mean heart rate was recorded. The first measured heart charge per unit was used as baseline middle rate. The divergence between the final 24 hours heart charge per unit at Calendar week 12 and of the baseline heart rate was calculated.

    
    

Information from the National Library of Medicine

Choosing to participate in a study is an important personal conclusion. Talk with your doctor and family members or friends about deciding to join a study. To learn more than most this written report, you or your doctor may contact the written report enquiry staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Report:	eighteen Years to lxx Years   (Developed, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Inclusion Criteria:

1. Subjects anile: >=18 years and =<lxx years former
2. EH who are suitable for mono-therapy, either mild to moderate EH patients who have not been treated with anti-hypertension drugs, or balmy EH subjects who have taken anti-hypertension drug.
3. Clinic resting Heart Charge per unit >=70 beats per infinitesimal (bpm)
4. Patients who have signed informed consent

Exclusion Criteria:

1. Subjects with contraindications co-ordinate to the Red china Summary of Product Characteristics (SmPCs) of both bisoprolol and metoprolol SR, such as acute heart failure, second or third degree atrioventricular block (without a pacemaker), ill sinus syndrome, symptomatic bradycardia or symptomatic hypotension, astringent bronchial asthma or severe chronic obstructive pulmonary disease, metabolic acidosis, etc.
2. Moderate EH patients who take used anti-hypertension drugs
3. Secondary hypertension
4. Subjects with history of coronary heart illness
5. Chronic or astute heart failure
6. Cerebrovascular events within 6 months before screening
7. Impaired hepatic or renal function (according to local lab standard)
8. Other protocol divers exclusion criteria could apply

Information from the National Library of Medicine

To learn more virtually this study, you or your doctor may contact the report inquiry staff using the contact information provided by the sponsor.

Delight refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01508325

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Cathay
Merck Serono Investigational Site
Changsha City, China

Merck KGaA, Darmstadt, Germany

Merck Serono Co., Ltd., Prc

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Study Manager:	Medical Managing director	Merck Serono Co., Ltd., China

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Responsible Political party:	Merck KGaA, Darmstadt, Federal republic of germany
ClinicalTrials.gov Identifier:	NCT01508325
Other Study ID Numbers:	EMR200006-520
First Posted:	January 11, 2012    Key Record Dates
Results Kickoff Posted:	May 13, 2015
Final Update Posted:	May 13, 2015
Terminal Verified:	April 2015

Keywords provided past Merck KGaA, Darmstadt, Frg:

Bisoprolol Hypertension Blood pressure Middle charge per unit

Boosted relevant MeSH terms:

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Hypertension Vascular Diseases Cardiovascular Diseases Metoprolol Bisoprolol Anti-Arrhythmia Agents Antihypertensive Agents Sympatholytics Autonomic Agents	Peripheral Nervous Organisation Agents Physiological Effects of Drugs Adrenergic beta-1 Receptor Antagonists Adrenergic beta-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action

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Source: https://clinicaltrials.gov/ct2/show/NCT01508325

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