An Active-controlled, Clinical Trial to Assess Central Hemodynamic Effects of Bisoprolol in Hypertensive Patients (Central Hemodynamic Assessment Measured in Patient With HypertensION [CHAMPION])

Launched by MERCK KGAA, DARMSTADT, GERMANY · Mar 2, 2010

Keywords

ClinConnect Summary

Central pulse pressure is a better predictor of left ventricular mass and carotid intima thickness, and the conventional peripheral BP does not seem to be an accurate reflection of central arterial BP. The pulse pressure amplification between peripheral and central arteries reflects the left ventricular afterload, subendothelial viability, and the intensity of cyclic stress imposed to the renal and cerebral micro- and macro vessels. As central hemodynamic parameters are independently associated with organ damage and are closely related to important cardiovascular outcome, it is suggested th...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • An antihypertensive-naive subject or a subject who has not been taking the previously administered antihypertensive agent for at least 4 weeks prior to screening
• • Subjects aged between 20 and 75 years, inclusive
• • Subjects with systolic blood pressure (SBP) greater than or equal to 140 millimeter of mercury (mmHg) and less than 180 mmHg or diastolic blood pressure (DBP) greater than or equal to 90 mmHg and less than 110 mmHg
• Exclusion Criteria:
• • Subjects with secondary hypertension
• • Subjects with renal impairment (Creatinine greater than 150 micromoles/liter \[mcmol/L\] or Creatinine greater than 1.7 mg/deciliter \[dL\])
• • Subjects with severe hypertension (Stage III) SBP greater than or equal to 180 mmHg or DBP greater than or equal to 110 mmHg
• • Subjects with congestive heart failure, acute myocardial infarction, unstable angina
• • Subjects with moderate bronchial asthma, chronic obstructive pulmonary disease
• • Subjects with symptomatic bradycardia, radial artery injury, second degree or third degree atrioventricular (AV) block, atrial fibrillation, atrial flutter, left bundle branch block (LBBB)
• • Subjects with a history of hypersensitivity to bisoprolol and atenolol products
• • Pregnancy or breastfeeding women