Clinical trial NCT01508325: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Keywords: Bisoprolol
Hypertension
Blood pressure
Heart rate
Lead sponsor: Merck KGaA, Darmstadt, Germany
Sponsor class: INDUSTRY
Collaborators: name: Merck Serono Co., Ltd., China
First posted: 2012-01-11
Enrollment: 186
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a multicentre, randomized, open-label 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.

Detailed description: Primary objectives:

To demonstrate that bisoprolol is superior in mean ambulatory heart rate and/or non-inferior in mean ambulatory DBP as compared with metoprolol SR in the last 4 hours after 12-week active treatment in subjects with mild 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 different times (Example: blood pressure, heart rate, their variability, etc...) after 12-week treatment from baseline among subjects with mild to moderate EH
2. To evaluate safety of the two drugs
3. To evaluate the treatment compliance of the two drugs

Eligibility criteria: Inclusion Criteria:

1. Subjects aged: \>=18 years and =\<70 years old
2. 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 subjects who have taken anti-hypertension drug.
3. Clinic resting Heart Rate \>=70 beats per minute (bpm)
4. Patients who have signed informed consent

Exclusion Criteria:

1. Subjects with contraindications according to the 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), 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. Subjects 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)
8. Other protocol defined exclusion criteria could apply

Primary outcomes:
measure: Change From Baseline in Mean Ambulatory Diastolic Blood Pressure (DBP) in the Last 4 Hours After 12-week Treatment
timeFrame: Baseline and Week 12
measure: Change From Baseline in Mean Heart Rate in the Last 4 Hours After 12-week Treatment
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Change From Baseline in Mean Ambulatory Systolic Blood Pressure (SBP) in the Last 4 Hours After 12-week Treatment
timeFrame: Baseline and Week 12
measure: Change From Baseline in Mean Ambulatory 24-hour Blood Pressure at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in Mean Ambulatory Daytime Blood Pressure at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in Mean Ambulatory Night-time Blood Pressure at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in Mean Ambulatory Daytime Heart Rate at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in Mean Ambulatory Night-time Heart Rate at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in 24-hour Blood Pressure Variability at Week 12
timeFrame: Baseline and Week 12
measure: Blood Pressure Response Rate
timeFrame: Week 12
measure: Heart Rate Response Rate
timeFrame: Week 12
measure: Change From Baseline in Mean Ambulatory 24-hour Heart Rate at Week 12
timeFrame: Baseline and Week 12
Other outcomes:
Locations:
city: Changsha City
country: China
facility: Merck Serono Investigational Site
Study officials:
affiliation: Merck Serono Co., Ltd., China
name: Medical Director
role: STUDY_DIRECTOR
References: