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

NACompletedINTERVENTIONAL
Enrollment

529

Participants

Timeline

Start Date

December 31, 2005

Primary Completion Date

June 30, 2006

Study Completion Date

August 31, 2006

Conditions
Hypertension
Interventions
DRUG

Felodipine tablet (Plendil) alone

Felodipine sustained release tablet single drug therapy (1st week- 2nd week) Eligible subjects will first take felodipine tablet 5mg, once daily, orally for 2 weeks. If blood pressure is controlled after 2 weeks, then the subjects will continue the treatment until the end of primary therapy stage (14th week).

DRUG

Felodipine tablet (Plendil)+Hydrochlorothiazide

"Step 1: Eligible subjects will first take felodipine tablet 5mg, once daily, orally for 2 weeks.~If blood pressure is not controlled after 2 weeks, then the subjects will go to Step 2: Felodipine sustained release tablet 5mg once daily combined with hydrochlorothiazide 12.5mg, once daily. If blood pressure is not controlled after 4 weeks, then the subjects will go to Step 3: The dosage of felodipine sustained release tablet will be escalated to 10mg, once daily, while the dosage of the combined drug remains the same. If blood pressure is not controlled after 4 weeks, then the subjects will go to Step 4: The dosage of felodipine sustained release tablet keeps 10mg, once daily, while the dosage of different combined drug is doubled."

DRUG

Felodipine tablet (Plendil)+Metoprolol tablet (Betaloc ZOK)

"Step 1: Eligible subjects will first take felodipine tablet 5mg, once daily, orally for 2 weeks.~If blood pressure is not controlled after 2 weeks, then the subjects will go to Step 2: Felodipine sustained release tablet 5mg once daily combined with metoprolol succinate prolonged-release tablet (Betaloc ZOK) 47.5mg , once daily. If blood pressure is not controlled after 4 weeks, then the subjects will go to Step 3: The dosage of felodipine sustained release tablet will be escalated to 10mg, once daily, while the dosage of the combined drug remains the same. If blood pressure is not controlled after 4 weeks, then the subjects will go to Step 4: The dosage of felodipine sustained release tablet keeps 10mg, once daily, while the dosage of different combined drug is doubled."

DRUG

Felodipine tablets (Plendil)+Lisinopril (Zestril)

"Step 1: Eligible subjects will first take felodipine tablet 5mg, once daily, orally for 2 weeks.~If blood pressure is not controlled after 2 weeks, then the subjects will go to Step 2: Felodipine sustained release tablet 5mg once daily combined with Lisinopril (Zestril) 10mg, once daily. If blood pressure is not controlled after 4 weeks, then the subjects will go to Step 3: The dosage of felodipine sustained release tablet will be escalated to 10mg, once daily, while the dosage of the combined drug remains the same. If blood pressure is not controlled after 4 weeks, then the subjects will go to Step 4: The dosage of felodipine sustained release tablet keeps 10mg, once daily, while the dosage of different combined drug is doubled."

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AstraZeneca

INDUSTRY