Comparison of Bisoprolol With Metoprolol Succinate Sustained-release on Heart Rate and Blood Pressure in Hypertensive Patients
Overview[ - collapse ][ - ]
Purpose | This is a multi-centre, randomized, open-label parallel trial to demonstrate the superiority and/or non-inferiority of bisoprolol on metoprolol succinate sustained-release (SR) |
---|---|
Condition | Hypertension |
Intervention | Drug: Bisoprolol Drug: Metoprolol |
Phase | Phase 4 |
Sponsor | Merck KGaA |
Responsible Party | Merck KGaA |
ClinicalTrials.gov Identifier | NCT01508325 |
First Received | January 9, 2012 |
Last Updated | February 10, 2014 |
Last verified | February 2014 |
Tracking Information[ + expand ][ + ]
First Received Date | January 9, 2012 |
---|---|
Last Updated Date | February 10, 2014 |
Start Date | December 2011 |
Estimated Primary Completion Date | March 2014 |
Current Primary Outcome Measures |
|
Current Secondary Outcome Measures |
|
Descriptive Information[ + expand ][ + ]
Brief Title | Comparison of Bisoprolol With Metoprolol Succinate Sustained-release on Heart Rate and Blood Pressure in Hypertensive Patients |
---|---|
Official Title | Comparison of Bisoprolol With Metoprolol Succinate Sustained-release on Heart Rate and Blood Pressure in Hypertensive Patients (CREATIVE Study) |
Brief Summary | This is a multi-centre, randomized, open-label parallel trial to demonstrate the superiority and/or non-inferiority of bisoprolol on metoprolol succinate sustained-release (SR) |
Detailed Description | Primary objectives: To demonstrate that bisoprolol is superior in mean ambulatory heart rate and/or non-inferior in mean ambulatory diastolic blood pressure as compared with metoprolol SR in the last 4 hours after 12-week active treatment in patients with mild to moderate essential hypertension. Secondary objectives: 1. To compare the efficacy of the 2 study drugs by 24h ambulatory monitoring by several parameters at different times (e.g. blood pressure, heart rate, their variability, etc...) after 12-week treatment from baseline among patients with mild to moderate essential hypertension 2. To evaluate the safety of these two study drugs 3. To evaluate the compliance of the two study drugs |
Study Type | Interventional |
Study Phase | Phase 4 |
Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care |
Condition | Hypertension |
Intervention | Drug: Bisoprolol Dose escalation schedule: 5mg 1/d to 7.5mg 1/d to 10mg 1/d. The active drug should be taken as close to 8am every morning. Every 4 weeks the dosage need to be up-titrated if the patient's blood pressure (BP) is ≥140 and/or 90mmHg. The first Ambulatory blood pressure monitoring (ABPM) is performed on the last day of the wash-out period. The second ABPM is performed on the last day of the active treatment. Other Names: ConcorDrug: Metoprolol Dose escalation schedule: 47.5mg 1/d to 71.25mg 1/d to 95mg 1/d. Comparison of different drug. Metoprolol succinate 47.5mg/tablet, oral |
Study Arm (s) |
|
Recruitment Information[ + expand ][ + ]
Recruitment Status | Active, not recruiting |
---|---|
Estimated Enrollment | 187 |
Estimated Completion Date | March 2014 |
Estimated Primary Completion Date | March 2014 |
Eligibility Criteria | Inclusion Criteria: 1. Patients aged: ≥18 years and ≤70 years old. 2. Essential hypertension (EH) who are suitable for mono-therapy, either mild to moderate EH patients who have not been treated with anti-hypertension drugs, or mild EH patients who have taken anti-hypertension drug. 3. Clinic resting Heart Rate (HR) ≥70bpm 4. Patients who have signed informed consent Exclusion Criteria: 1. Patients with contraindications according to the China Summary of Product Characteristics (SPCs) of both bisoprolol and metoprolol SR, such as acute heart failure, second or third degree atrioventricular block (without a pacemaker), sick sinus syndrome, symptomatic bradycardia or symptomatic hypotension, severe bronchial asthma or severe chronic obstructive pulmonary disease, metabolic acidosis, etc. 2. Moderate EH patients who have used anti-hypertension drugs 3. Secondary hypertension 4. Patients with history of coronary heart disease 5. Chronic or acute heart failure 6. Cerebrovascular events within 6 months before screening 7. Impaired hepatic or renal function (according to local lab standard) |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | China |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01508325 |
---|---|
Other Study ID Numbers | EMR200006-520 |
Has Data Monitoring Committee | No |
Information Provided By | Merck KGaA |
Study Sponsor | Merck KGaA |
Collaborators | Merck Serono Co., Ltd., China |
Investigators | Study Director: Medical Director Merck Serono Co., Ltd., China |
Verification Date | February 2014 |
Locations[ + expand ][ + ]
Merck Serono Investigational Site | Changsha City, China |
---|