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

Information source: Merck KGaA
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

Intervention: Bisoprolol (Drug); Metoprolol (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Merck KGaA

Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Merck Serono Co., Ltd., China

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Primary outcome:

Change From Baseline in Mean Ambulatory Diastolic Blood Pressure (DBP) in the Last 4 Hours After 12-week Treatment

Change From Baseline in Mean Heart Rate in the Last 4 Hours After 12-week Treatment

Secondary outcome:

Change From Baseline in Mean Ambulatory Systolic Blood Pressure (SBP) in the Last 4 Hours After 12-week Treatment

Change From Baseline in Mean Ambulatory 24-hour Blood Pressure at Week 12

Change From Baseline in Mean Ambulatory Daytime Blood Pressure at Week 12

Change From Baseline in Mean Ambulatory Night-time Blood Pressure at Week 12

Change From Baseline in Mean Ambulatory Daytime Heart Rate at Week 12

Change From Baseline in Mean Ambulatory Night-time Heart Rate at Week 12

Change From Baseline in 24-hour Blood Pressure Variability at Week 12

Blood Pressure Response Rate

Heart Rate Response Rate

Change From Baseline in Mean Ambulatory 24-hour Heart Rate at Week 12

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

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

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

Locations and Contacts

Merck Serono Investigational Site, Changsha City, China
Additional Information

Starting date: December 2011
Last updated: April 28, 2015

Page last updated: August 23, 2015

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