EFFICACY AND TOLERABILITY OF BISOPROLOL IN COMPARISON TO METOPROLO

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 200

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

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
1.Percentage of patients requiring dose titration at 4 & 8 weeks.<br>2.Change in the mean blood pressure from baseline at 4, 8 and 12 weeks.<br>3.Change in the mean night-time blood pressure from baseline at 4, 8 and 12 weeks. <br>4.Global efficacy and tolerability assessment on a four-point scale<br>Timepoint: 0 week, 4 week, 8 week, and 12 week