None listed
Conditions
Interventions
Intervention1: Bisoprolol: 5 mg, oral, once a day
Control Intervention1: metoprolol (Extended Release): 50 mg, oral, once a day
Sponsors
Investigator (Rajiv KArnik)
Pharmakeez
Eligibility
Inclusion criteria
Inclusion criteria: 1) Be male or female between the ages 18 to 65 years; 2) New patients (treatment naïve) with diagnosis of stage-I hypertension (SBP 140-159 mm Hg or DBP 90-99 mm Hg); 3) Current physical examination and vital signs at screening that reveals no clinically significant abnormalities; 4) Willing and able to follow the instructions and procedures of the study including 24 hour continuous ambulatory cardiac monitoring; 5) Willing to give written informed consent prior to admission into the study; and 6) If female of childbearing potential, must be using a reliable form of birth control and be willing to continue as such for the duration of the study.
Exclusion criteria
Exclusion criteria: 1. Confirmed diagnosis of unstable angina; 2. History of Acute Myocardial Infarction (AMI) or cardiac surgery within the preceding 6 months; 3. Has uncompensated congestive heart failure (CHF); 4. Has uncontrolled atrial fibrillation; 5. Having bradycardia defined as a pulse rate below 50 beats per minute; 6. Has bronchial asthma or Chronic obstructive pulmonary disease (COPD); 7. Has Insulin-dependent diabetes mellitus; 8. Have a history suggestive of, or presence of significant, gastrointestinal, endocrine, neurological, liver, or kidney disease, or conditions known to interfere with the absorption, distribution, metabolism, or excretion of study drugs; 9. Have a history of drug or alcohol dependency or psychological disease; 10. Require regular use of medication (other than study medication) that interferes with the absorption and/or metabolism of study drugs (e.g., steroids); 11. Participation in a clinical trial or use of an investigational drug within 30 days prior to admission to this study; 12. Have any acute illness within 2 weeks prior to screening; 13. Have known significant hepatic & renal impairment; 14. Subjects who have participated in any clinical trial or use of an investigational drug within 30 days prior to admission to this study; 15. Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Responder rate at 12 weeks: Defined as percentage (%) of patients achieving BP <140/ 90 mm Hg throughout 24 hours.Timepoint: 0 week, 4 week, 8 week, and 12 week | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Percentage of patients requiring dose titration at 4 & 8 weeks. 2.Change in the mean blood pressure from baseline at 4, 8 and 12 weeks. 3.Change in the mean night-time blood pressure from baseline at 4, 8 and 12 weeks. 4.Global efficacy and tolerability assessment on a four-point scale Timepoint: 0 week, 4 week, 8 week, and 12 week | — |
Countries
India
Contacts
Public ContactDr. Amit Garg
Outcome results
None listed