Antihypertensive Efficacy of Fixed Combination Drug

• Status: Terminated
• Trial end date: 2012-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Treatment and control of hypertension is still insufficient. About 50% of the patients remain uncontrolled. Lack of compliance with discontinuation of drug treatment is an important reason for not achieving blood pressure. Several studies have shown that use of fixed combinations improve compliance significantly, by reducing the number of pill's intake.

This study will assess the antihypertensive efficacy of Vasodip-Combo 20® [enalapril 20 mg + lercanidipine 10 mg] as a fixed combination drug in uncontrolled antihypertensive patients.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Meir Medical Center
• Collaborator: Dexcel Pharma Technologies Ltd.
• Treatments: Enalapril; Enalaprilat; Lercanidipine

Criteria

Inclusion Criteria:

1. Essential hypertension at visit 1 defined as office blood pressure <140/90 mmHg and a 24 h ABPM >130/80 mmHg with a day time blood pressure (extracted from the 24h ABPM) >135/85 mmHg

2. Male and female

3. Age 18-80

4. Every patient that in the medical opinion of the treating physician is eligible for Vasodip Combo 20 treatment.

5. Willing to sign an informed consent

Exclusion Criteria:

1. Use of more than 2 anti hypertensive medication at visit 1 (fixed combination is considered as two drugs)

2. Mean 24 h ABPM values of more than 180/100 mmHg

3. Pregnant women

4. Women with potential age of pregnancy.

5. Suspected secondary hypertension (investigator decision)

6. Uncontrolled Diabetes Mellitus(investigator decision)

7. Any of the following in the last six months: Myocardial Infarction, Stroke, Coronary by-pass surgery, Percutaneous coronariography with balloon dilation and/or stent insertion

8. Congestive Heart Failure requiring pharmacological treatment

9. Renal Failure, defined as serum creatinine equal or great than 1.5 mg% [confirmed twice] or hyperkalemia defined as serum potassium equal or great that 5 meq/l [confirmed twice]

10. Malignancy that required Chemotherapy in the last 3 years.

11. Any medical or none medical condition that in the eyes of the investigator will not allow the patient to complete the study.