The effects on blood pressure control, pulse wave velocity, as well as safety and tolerability of felodipine sustained release in Chinese patients.

Study identifier:D4385L00001

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A randomized, open-label study to evaluate the effects on blood pressure control, pulse wave velocity, as well as safety and tolerability of felodipine sustained release, alone and in combination with metoprolol, lisinopril or hydrochlorothiazide, in Chinese patients with mild to moderate essential hypertension.

Medical condition

hypertension

Phase

N/A

Healthy volunteers

Study drug

Felodipine tablet (Plendil) alone, Felodipine tablet (Plendil)+Hydrochlorothiazide, Felodipine tablet (Plendil)+Metoprolol tablet (Betaloc ZOK), Felodipine tablets (Plendil)+Lisinopril (Zestril)

Sex

All

Actual Enrollment

529

Study type

Interventional

Age

35 Years - 79 Years

Date

Study Start Date: 01 Dec 2005

Primary Completion Date: 01 Jun 2006

Study Completion Date: 01 Aug 2006

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: -

Verification:

Verified 01 Mar 2015 by AstraZeneca

Collaborators

Inclusion and exclusion 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.

No locations available

Arms	Assigned Interventions
Experimental: Felodipine tablet (Plendil)	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).
Active Comparator: Felodipine tablet (Plendil)+Metoprolol tablet (Betaloc ZOK)	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.
Active Comparator: Felodipine tablets (Plendil)+Lisinopril (Zestril)	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.
Active Comparator: Felodipine tablet (Plendil)+Hydrochlorothiazide	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.

Documents available

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CSR-D4385L00001.pdf
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Trial Results Summaries
Available here

Contacts

Contact

Ningling Sun

010-66583666

[email protected]

Investigators

Principal Investigator