The Effects on Blood Pressure Control, Pulse Wave Velocity, as Well as Safety and Tolerability of Felodipine Sustained Release in Chinese Patients.

• Status: Completed
• Trial end date: 2006-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the effects on blood pressure control, pulse wave velocity, as well as safety and tolerability of felodipine single or combine with other drugs in Chinese Hypertension patients.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Felodipine; Hydrochlorothiazide; Lisinopril; Metoprolol

Criteria

Inclusion Criteria:

1. Provision of written informed consent

2. Female or male aged between 35-79 years old

3. Mild to moderate essential hypertension patients who meet any of the following criterias:

• Newly diagnosed, drug-naive, or without any antihypertension treatment for at least 3 months, moderate essential hypertension patients. (160mmHg mean SiSBP 180mmHg or 100mmHg mean SiDBP 110mmHg)

• Newly diagnosed, drug-naive, or without any antihypertension treatment for at least 3 months, mild essential hypertension patients (140mmHg mean SiSBP 160mmHg or 90mmHg mean SiDBP 100mmHg) with high or extreme high cardiovascular risk (a)(having 3 or more than 3 risk factors and/or target organ lesion and/or diabetes mellitus).

(a) according to Chinese guideline for prevention and treatment of patients with hypertension 2004.

• The patients have already received starting dosage of single anti-hypertension drug therapy (exclude the drugs containing felodipine component ), however the blood pressure is not well controlled (140mmHg mean SiSBP 160mmHg or 90mmHg mean SiDBP 100mmHg). After stopping the drug for 5 eliminating half life time, the patients meet any one of the following two:

1. 160mmHg mean SiSBP 180mmHg or 100mmHg mean SiDBP 110mmHg.

2. 140mmHg mean SiSBP 160mmHg or 90mmHg mean SiDBP 100mmHg) with high or extreme high cardiovascular risk* (having 3 or more than 3 risk factors and/or target organ lesion and/or diabetes mellitus).

Sitting blood pressure is taken after subjects take a seat to rest for 5 minutes before the next medication.

Exclusion Criteria:

Any of the following is regarded as a criterion for exclusion from the study:

1. Known or suspected secondary hypertension

2. Resting heart rate is < 55bpm.

3. Sick sinus syndrome

4. Atrioventricular block of first degree (with P-R>0.24seconds), or second or third degree

5. Other clinical significant arrhythmia

6. Unstable and/or decompensated congestive heart failure

7. Angina, acute myocardial infarction, percutaneous coronary intervention (PCI), or cardiac surgery

8. Asthma or moderate to severe chronic obstructive pulmonary disease

9. Type 1 diabetes mellitus

10. Gout history

11. Fasting serum glucose of greater than 200 mg/dl (11.1 mmol/L) or type 2 diabetes mellitus needs insulin therapy

12. ALT>3ULN

13. Cr>1.5mg/dl

14. Pregnancy or lactation.

15. Alcohol or drug abuse

16. Known need for other concomitant anti-hypertensive therapy during the study besides the study drug.

17. Known or suspected allergy to investigational drug or non-active ingredients of investigational drugs, known allergy to other blockers, calcium antagonist, diuretics, angiotensin converting enzyme inhibitor or with other contraindications.

18. Suspected white-coat hypertension based on investigator's judgement.