Efficacy, Safety and Pharmacodynamic/Pharmacokinetic Study of Fimasartan (BR-A-657•K)

• Status: Completed
• Trial end date: 2006-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Study objective:

1. To evaluate the antihypertensive efficacy, safety and tolerability of the drug after the oral administration of BR-A-657•K at 20~180mg for 4 weeks to patients with essential hypertension.

2. To review the pharmacokinetic profile after the multiple administration and the pharmacodynamic profile regarding the renin-angiotensin system, after the oral administration of BR-A-657•K at 20~180mg for 4 weeks to patients with essential hypertension.

3. To determine the dose for the clinical study at the next phase by analyzing the relationship between the antihypertensive efficacy and pharmacokinetic • pharmacodynamic results.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boryung Pharmaceutical Co., Ltd

Criteria

Inclusion Criteria:

• Adult men and women, aged 18 - 65

• Patients with mild to moderate essential hypertension: On both screening and Day -1 visit, mean sitting DBP should be ≥ 95mmHg and ≤ 114mmHg, and ΔDBP on Day -14 and Day -1 should be within 7 mmHg

• Patients who gave their consent to participate in this study and signed the written informed consent form

• Patients who have understood the study, and been judged to be cooperative and able to participate in the study until the study completion date

Exclusion Criteria:

1. Women of childbearing potential who have not received the hysterectomy or men who are not willing to use birth control measures.

2. Patients whose sitting DBP is < 95mmHg or ≥ 115mmHg. Patients with severe hypertension whose SBP is ≥200mmHg

3. Patients with secondary hypertension

4. Patients with severe renal disease, gastrointestinal disorder, hematologic disorder, liver disease, etc. that can affect the absorption, distribution, metabolism and excretion of drugs

5. Patients with symptoms of orthostatic hypotension

6. Patients with severe insulin dependent diabetes or uncontrolled diabetes

7. Patients who suffered myocardial infarction or serious coronary arterial disease over the past 6 months or patients with clinically significant congestive heart failure or valvular heart disease

8. Patients with consumption disease, autoimmune disease, or connective tissue disease

9. Patients with the history of type B hepatitis or type C hepatitis

10. Patients with HIV infection or hepatitis

11. Patients with clinically significant abnormal laboratory test findings

12. Patients on any drug treatment that might affect the blood pressure

13. Patients with allergy or contraindication to angiotensin II-receptor antagonists

14. Patients with current or suspected alcohol addiction or history of drug abuse

15. Patients whose mean weight lies out of the range of -15% ~ +35%, based on the Modified Metropolitan Life Insurance table

16. Patients who are not eligible as subjects of the study, as determined by the principal investigator or a sub-investigator