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

• Sponsor: AstraZeneca (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02336607
• Collaborator: (none)
• Enrollment: 529
• Arms: 4
• Duration (Months): 8

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension	Drug: Felodipine tablet (Plendil) alone; Drug: Felodipine tablet (Plendil)+Hydrochlorothiazide; Drug: Felodipine tablet (Plendil)+Metoprolol tablet (Betaloc ZOK); Drug: Felodipine tablets (Plendil)+Lisinopril (Zestril)	N/A

Detailed Description

In this study, investigators will choose male and female subjects aged between 35 and 79 years old with mild to moderate essential hypertension. At first 2 weeks, all patients will use felodipine 5mg daily. If the blood pressure dosen't meet the target (140/90mmHg), they will be randomized into metoprolol, lisinopril or hydrochlorothiazide combination groups for another 4 weeks therapy. After that, if the blood pressure has still not met the target, up-titrate the felodipine into 10mg, followed by a 4 weeks therapy. And if the blood pressure is still not met the target after that, up-titrate the combine drugs into maximum dosage. The whole treatment duration is 14 weeks.

The primary outcome is to evaluate the percentage of subjects reaching blood pressure target (defined as < 140 / 90 mmHg) after 14 weeks treatment with felodipine sustained release in combination with metoprolol, lisinopril or hydrochlorothiazide.

Study Design

• Study Type: Interventional
• Actual Enrollment: 529 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• 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.
• Study Start Date: Dec 1, 2005
• Actual Primary Completion Date: Jun 1, 2006
• Actual Study Completion Date: Aug 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. The Percentage of Subjects Reaching Blood Pressure Target (Defined as < 140 / 90 mmHg) After 14 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide. [14 weeks]

Secondary Outcome Measures

1. The Percentage of Subjects Reaching Blood Pressure Target (Defined as < 140 / 90 mmHg) After 4 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide. [4 weeks]

   The duration of the combination therapy was 4 weeks. Blood pressure was measured at week 6 of the trial.

2. The Percentage of Subjects Reaching Blood Pressure Target (Defined as < 140 / 90 mmHg) After 8 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide. [8 weeks]

   The duration of the combination therapy was 8 weeks. Blood pressure was measured at week 10 of the trial.

3. The Magnitude of Systolic and Diastolic Blood Pressure Change From Baseline Among All Randomized Subjects After 4 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide. [4 weeks]

   The duration of the combination therapy was 4 weeks. Blood pressure was measured at week 6 of the trial.

4. The Magnitude of Systolic and Diastolic Blood Pressure Changes From Baseline Among All Randomized Subjects After 8 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide. [8 weeks]

   The duration of the combination therapy was 8 weeks. Blood pressure was measured at week 10 of the trial.

5. The Magnitude of Systolic and Diastolic Blood Pressure Changes From Baseline Among All Randomized Subjects After 12 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide. [12 weeks]

   The duration of the combination therapy was 12 weeks. Blood pressure was measured at week 14 of the trial.

6. The Magnitude of Systolic and Diastolic Blood Pressure Changes From Baseline Among the Subjects Who Reached Target at 4 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide. [4 weeks]

   The duration of the combination therapy was 4 weeks. Blood pressure was measured at week 6 of the trial.

7. The Magnitude of Systolic and Diastolic Blood Pressure Changes From Baseline Among the Subjects Who Reached Target After 8 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide. [8 weeks]

   The duration of the combination therapy was 8 weeks. Blood pressure was measured at week 10 of the trial.

8. The Magnitude of Systolic and Diastolic Blood Pressure Changes From Baseline Among the Subjects Who Reached Target at 12 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide. [12 weeks]

   The duration of the combination therapy was 12 weeks. Blood pressure was measured at week 14 of the trial.

9. The Change of Pulse Wave Velocity at 12 Weeks Compare With Baseline Data of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide. [12 weeks]

   The duration of the combination therapy was 12 weeks. The change of pulse wave velocity was measured at week 14 of the trial.

10. The Change of Pulse Wave Velocity From Baseline at 2, 14 Weeks of Felodipine Sustained Release Alone. [12 weeks]

    The duration of the combination therapy was 12 weeks. The change of pulse wave velocity was measured at week 14 of the trial.

11. The Magnitude of Systolic and Diastolic Blood Pressure Changes From Baseline Among the Subjects Who Reached Target at 2 Weeks of Felodipine Sustained Release, Alone [2 weeks]

    The duration of the combination therapy was 2 weeks. Blood pressure was measured at week 2 of the trial.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 35 Years to 79 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• AstraZeneca

Investigators

• Principal Investigator: Ningling Sun, PhD, MD, Beijing University People's Hospital, Department of Cardiology

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info
• CSR-D4385L00001.pdf

Publications

None provided.

• Responsible Party: AstraZeneca
• ClinicalTrials.gov Identifier: NCT02336607
• Other Study ID Numbers: D4385L00001
• First Posted: Jan 13, 2015
• Last Update Posted: Mar 23, 2015
• Last Verified: Mar 1, 2015

• Additional relevant MeSH terms: Hypertension; Metoprolol; Felodipine; Hydrochlorothiazide; Lisinopril

Study Results

Participant Flow

Recruitment Details	Patients enrolled in 10 centers in the People's Republic of China. First patient screened on 26th Dec. 2005, last patient completed last visit on 17th Aug. 2006. A total of 529 patients attended the screening visit. ITT population (481),PP population (390), Safety population (522).
Pre-assignment Detail	After enrollment, 7 did not take the test medicine, 522 were given felodipine 5 mg once daily. Of these, 38 patients did not complete the 2-week felodipine monotherapy period.

Arm/Group Title	Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK)	Felodipine Tablets (Plendil)+Lisinopril (Zestril)	Felodipine Tablet (Plendil)+Hydrochlorothiazide	Felodipine Tablet (Plendil)
Arm/Group Description	Felodipine ER 5mg qd + Metoprolol ER 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Metoprolol 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Metoprolol 95mg qd till the end of the study (week 14).	Felodipine ER 5mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Lisinopril 20mg qd till the end of the study ( week 14).	Felodipine ER 5mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Hydrochlorothiazide 25mg qd till the end of the study (week 14).	Felodipine ER 5mg qd, the patients who didn't achive the target blood pressure (140/90) after 2 weeks (week1 and week2), switch to combination thearapies.
Period Title: Overall Study
STARTED	85	85	92	267
Patients Included in ITT Population	84	84	91	222
Patients Included in PP Population	78	75	75	162
Patients Included in Safety Population	85	85	92	260
COMPLETED	81	75	86	180
NOT COMPLETED	4	10	6	87

Baseline Characteristics

Arm/Group Title	Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK)	Felodipine Tablets (Plendil)+Lisinopril (Zestril)	Felodipine Tablet (Plendil)+Hydrochlorothiazide	Felodipine Tablet (Plendil)	Total
Arm/Group Description	Felodipine ER 5mg qd + Metoprolol ER 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Metoprolol 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Metoprolol 95mg qd till the end of the study (week 14).	Felodipine ER 5mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Lisinopril 20mg qd till the end of the study ( week 14).	Felodipine ER 5mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Hydrochlorothiazide 25mg qd till the end of the study (week 14).	Felodipine ER 5mg qd, the patients who didn't achive the target blood pressure (140/90) after 2 weeks (week1 and week2), switch to combination thearapies.	Total of all reporting groups
Overall Participants	84	84	91	222	481
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	53.4 (10.8)	55.2 (10.7)	55.6 (9.9)	55 (11.3)	54.9 (10.8)
Sex: Female, Male (Count of Participants)
Female	35 41.7%	35 41.7%	35 38.5%	110 49.5%	215 44.7%
Male	49 58.3%	49 58.3%	56 61.5%	112 50.5%	266 55.3%

Outcome Measures

1. Primary Outcome

Title	The Percentage of Subjects Reaching Blood Pressure Target (Defined as < 140 / 90 mmHg) After 14 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide.
Time Frame	14 weeks

Outcome Measure Data

Analysis Population Description

The ITT population was defined as all patients who received at least one dose of study drug after randomization and had measurements of blood pressure at baseline and from at least one visit after randomization.

Arm/Group Title	Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK)	Felodipine Tablets (Plendil)+Lisinopril (Zestril)	Felodipine Tablet (Plendil)+Hydrochlorothiazide	Felodipine Tablet (Plendil)
Arm/Group Description	Felodipine ER 5mg qd + Metoprolol ER 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Metoprolol 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Metoprolol 95mg qd till the end of the study (week 14).	Felodipine ER 5mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Lisinopril 20mg qd till the end of the study ( week 14).	Felodipine ER 5mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Hydrochlorothiazide 25mg qd till the end of the study (week 14).	Felodipine ER 5mg qd, the patients who didn't achive the target blood pressure (140/90) after 2 weeks (week1 and week2), switch to combination thearapies.
Measure Participants	78	75	75	181
Number (95% Confidence Interval) [Percentage]	74.1	80.5	80.2	NA

2. Secondary Outcome

Title	The Percentage of Subjects Reaching Blood Pressure Target (Defined as < 140 / 90 mmHg) After 4 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide.
Description	The duration of the combination therapy was 4 weeks. Blood pressure was measured at week 6 of the trial.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

The ITT population was defined as all patients who received at least one dose of study drug after randomization and had measurements of blood pressure at baseline and from at least one visit after randomization.

Arm/Group Title	Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK)	Felodipine Tablets (Plendil)+Lisinopril (Zestril)	Felodipine Tablet (Plendil)+Hydrochlorothiazide	Felodipine Tablet (Plendil)
Arm/Group Description	Felodipine ER 5mg qd + Metoprolol ER 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Metoprolol 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Metoprolol 95mg qd till the end of the study (week 14).	Felodipine ER 5mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Lisinopril 20mg qd till the end of the study ( week 14).	Felodipine ER 5mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Hydrochlorothiazide 25mg qd till the end of the study (week 14).	Felodipine ER 5mg qd, the patients who didn't achive the target blood pressure (140/90) after 2 weeks (week1 and week2), switch to combination thearapies.
Measure Participants	83	84	91	193
Number (95% Confidence Interval) [Percentage]	45.8	59.5	46.2	NA

3. Secondary Outcome

Title	The Percentage of Subjects Reaching Blood Pressure Target (Defined as < 140 / 90 mmHg) After 8 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide.
Description	The duration of the combination therapy was 8 weeks. Blood pressure was measured at week 10 of the trial.
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

The ITT population was defined as all patients who received at least one dose of study drug after randomization and had measurements of blood pressure at baseline and from at least one visit after randomization.

Arm/Group Title	Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK)	Felodipine Tablets (Plendil)+Lisinopril (Zestril)	Felodipine Tablet (Plendil)+Hydrochlorothiazide	Felodipine Tablet (Plendil)
Arm/Group Description	Felodipine ER 5mg qd + Metoprolol ER 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Metoprolol 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Metoprolol 95mg qd till the end of the study (week 14).	Felodipine ER 5mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Lisinopril 20mg qd till the end of the study ( week 14).	Felodipine ER 5mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Hydrochlorothiazide 25mg qd till the end of the study (week 14).	Felodipine ER 5mg qd, the patients who didn't achive the target blood pressure (140/90) after 2 weeks (week1 and week2), switch to combination thearapies.
Measure Participants	84	81	89	181
Number (95% Confidence Interval) [Percentage]	78.6	79	78.7	NA

4. Secondary Outcome

Title	The Magnitude of Systolic and Diastolic Blood Pressure Change From Baseline Among All Randomized Subjects After 4 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide.
Description	The duration of the combination therapy was 4 weeks. Blood pressure was measured at week 6 of the trial.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

The ITT population was defined as all patients who received at least one dose of study drug after randomization and had measurements of blood pressure at baseline and from at least one visit after randomization.

Arm/Group Title	Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK)	Felodipine Tablets (Plendil)+Lisinopril (Zestril)	Felodipine Tablet (Plendil)+Hydrochlorothiazide	Felodipine Tablet (Plendil)
Arm/Group Description	Felodipine ER 5mg qd + Metoprolol ER 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Metoprolol 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Metoprolol 95mg qd till the end of the study (week 14).	Felodipine ER 5mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Lisinopril 20mg qd till the end of the study ( week 14).	Felodipine ER 5mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Hydrochlorothiazide 25mg qd till the end of the study (week 14).	Felodipine ER 5mg qd, the patients who didn't achive the target blood pressure (140/90) after 2 weeks (week1 and week2), switch to combination thearapies.
Measure Participants	83	84	91	193
Change of systolic blood pressure	-10.3 (2.0)	-13.4 (1.8)	-9.8 (1.4)	NA (NA)
Change of diastolic blood pressure	-7.3 (1.5)	-9.9 (1.4)	-6.0 (1.0)	NA (NA)

5. Secondary Outcome

Title	The Magnitude of Systolic and Diastolic Blood Pressure Changes From Baseline Among All Randomized Subjects After 8 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide.
Description	The duration of the combination therapy was 8 weeks. Blood pressure was measured at week 10 of the trial.
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

The ITT population was defined as all patients who received at least one dose of study drug after randomization and had measurements of blood pressure at baseline and from at least one visit after randomization.

Arm/Group Title	Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK)	Felodipine Tablets (Plendil)+Lisinopril (Zestril)	Felodipine Tablet (Plendil)+Hydrochlorothiazide	Felodipine Tablet (Plendil)
Arm/Group Description	Felodipine ER 5mg qd + Metoprolol ER 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Metoprolol 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Metoprolol 95mg qd till the end of the study (week 14).	Felodipine ER 5mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Lisinopril 20mg qd till the end of the study ( week 14).	Felodipine ER 5mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Hydrochlorothiazide 25mg qd till the end of the study (week 14).	Felodipine ER 5mg qd, the patients who didn't achive the target blood pressure (140/90) after 2 weeks (week1 and week2), switch to combination thearapies.
Measure Participants	84	81	89	181
Change of systolic blood pressure	-17.8 (2.2)	-18.0 (1.9)	-16.4 (1.5)	NA (NA)
Change of diastolic blood pressure	-11.3 (1.3)	-12.1 (1.2)	-10.7 (0.9)	NA (NA)

6. Secondary Outcome

Title	The Magnitude of Systolic and Diastolic Blood Pressure Changes From Baseline Among All Randomized Subjects After 12 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide.
Description	The duration of the combination therapy was 12 weeks. Blood pressure was measured at week 14 of the trial.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

The ITT population was defined as all patients who received at least one dose of study drug after randomization and had measurements of blood pressure at baseline and from at least one visit after randomization.

Arm/Group Title	Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK)	Felodipine Tablets (Plendil)+Lisinopril (Zestril)	Felodipine Tablet (Plendil)+Hydrochlorothiazide	Felodipine Tablet (Plendil)
Arm/Group Description	Felodipine ER 5mg qd + Metoprolol ER 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Metoprolol 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Metoprolol 95mg qd till the end of the study (week 14).	Felodipine ER 5mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Lisinopril 20mg qd till the end of the study ( week 14).	Felodipine ER 5mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Hydrochlorothiazide 25mg qd till the end of the study (week 14).	Felodipine ER 5mg qd, the patients who didn't achive the target blood pressure (140/90) after 2 weeks (week1 and week2), switch to combination thearapies.
Measure Participants	81	77	86	181
Change of systolic blood pressure	-16.6 (2.1)	-18.0 (1.9)	-16.8 (1.4)	NA (NA)
Change of diastolic blood pressure	-10.7 (1.5)	-12.8 (1.3)	-10.6 (1.0)	NA (NA)

7. Secondary Outcome

Title	The Magnitude of Systolic and Diastolic Blood Pressure Changes From Baseline Among the Subjects Who Reached Target at 4 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide.
Description	The duration of the combination therapy was 4 weeks. Blood pressure was measured at week 6 of the trial.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

The ITT population was defined as all patients who received at least one dose of study drug after randomization and had measurements of blood pressure at baseline and from at least one visit after randomization.

Arm/Group Title	Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK)	Felodipine Tablets (Plendil)+Lisinopril (Zestril)	Felodipine Tablet (Plendil)+Hydrochlorothiazide	Felodipine Tablet (Plendil)
Arm/Group Description	Felodipine ER 5mg qd + Metoprolol ER 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Metoprolol 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Metoprolol 95mg qd till the end of the study (week 14).	Felodipine ER 5mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Lisinopril 20mg qd till the end of the study ( week 14).	Felodipine ER 5mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Hydrochlorothiazide 25mg qd till the end of the study (week 14).	Felodipine ER 5mg qd, the patients who didn't achive the target blood pressure (140/90) after 2 weeks (week1 and week2), switch to combination thearapies.
Measure Participants	38	50	42	190
Change of systolic blood pressure	-16.1 (2.2)	-17.1 (1.6)	-16.4 (1.4)	NA (NA)
Change of diastolic blood pressure	-12.3 (1.6)	-10.9 (1.2)	-8.2 (1.0)	NA (NA)

8. Secondary Outcome

Title	The Magnitude of Systolic and Diastolic Blood Pressure Changes From Baseline Among the Subjects Who Reached Target After 8 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide.
Description	The duration of the combination therapy was 8 weeks. Blood pressure was measured at week 10 of the trial.
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

The ITT population was defined as all patients who received at least one dose of study drug after randomization and had measurements of blood pressure at baseline and from at least one visit after randomization.

Arm/Group Title	Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK)	Felodipine Tablets (Plendil)+Lisinopril (Zestril)	Felodipine Tablet (Plendil)+Hydrochlorothiazide	Felodipine Tablet (Plendil)
Arm/Group Description	Felodipine ER 5mg qd + Metoprolol ER 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Metoprolol 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Metoprolol 95mg qd till the end of the study (week 14).	Felodipine ER 5mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Lisinopril 20mg qd till the end of the study ( week 14).	Felodipine ER 5mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Hydrochlorothiazide 25mg qd till the end of the study (week 14).	Felodipine ER 5mg qd, the patients who didn't achive the target blood pressure (140/90) after 2 weeks (week1 and week2), switch to combination thearapies.
Measure Participants	66	64	70	180
Change of systolic blood pressure	-19.4 (1.6)	-19.7 (1.4)	-18.5 (1.1)	NA (NA)
Change of diastolic blood pressure	-13.4 (1.1)	-13.1 (0.9)	-11.5 (0.7)	NA (NA)

9. Secondary Outcome

Title	The Magnitude of Systolic and Diastolic Blood Pressure Changes From Baseline Among the Subjects Who Reached Target at 12 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide.
Description	The duration of the combination therapy was 12 weeks. Blood pressure was measured at week 14 of the trial.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

The ITT population was defined as all patients who received at least one dose of study drug after randomization and had measurements of blood pressure at baseline and from at least one visit after randomization.

Arm/Group Title	Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK)	Felodipine Tablets (Plendil)+Lisinopril (Zestril)	Felodipine Tablet (Plendil)+Hydrochlorothiazide	Felodipine Tablet (Plendil)
Arm/Group Description	Felodipine ER 5mg qd + Metoprolol ER 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Metoprolol 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Metoprolol 95mg qd till the end of the study (week 14).	Felodipine ER 5mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Lisinopril 20mg qd till the end of the study ( week 14).	Felodipine ER 5mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Hydrochlorothiazide 25mg qd till the end of the study (week 14).	Felodipine ER 5mg qd, the patients who didn't achive the target blood pressure (140/90) after 2 weeks (week1 and week2), switch to combination thearapies.
Measure Participants	60	62	69	176
Change of systolic blood pressure	-18.4 (1.7)	-20.3 (1.5)	-18.2 (1.2)	NA (NA)
Change of diastolic blood pressure	-13.0 (1.2)	-13.6 (1.1)	-12.2 (0.8)	NA (NA)

10. Secondary Outcome

Title	The Change of Pulse Wave Velocity at 12 Weeks Compare With Baseline Data of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide.
Description	The duration of the combination therapy was 12 weeks. The change of pulse wave velocity was measured at week 14 of the trial.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

The ITT population was defined as all patients who received at least one dose of study drug after randomization and had measurements of blood pressure at baseline and from at least one visit after randomization.

Arm/Group Title	Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK)	Felodipine Tablets (Plendil)+Lisinopril (Zestril)	Felodipine Tablet (Plendil)+Hydrochlorothiazide	Felodipine Tablet (Plendil)
Arm/Group Description	Felodipine ER 5mg qd + Metoprolol ER 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Metoprolol 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Metoprolol 95mg qd till the end of the study (week 14).	Felodipine ER 5mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Lisinopril 20mg qd till the end of the study ( week 14).	Felodipine ER 5mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Hydrochlorothiazide 25mg qd till the end of the study (week 14).	Felodipine ER 5mg qd, the patients who didn't achive the target blood pressure (140/90) after 2 weeks (week1 and week2), switch to combination thearapies.
Measure Participants	33	32	35	181
Mean (Standard Deviation) [m/s]	-0.12 (0.27)	-0.44 (0.38)	-0.06 (0.27)	NA (NA)

11. Secondary Outcome

Title	The Change of Pulse Wave Velocity From Baseline at 2, 14 Weeks of Felodipine Sustained Release Alone.
Description	The duration of the combination therapy was 12 weeks. The change of pulse wave velocity was measured at week 14 of the trial.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

The ITT population was defined as all patients who received at least one dose of study drug after randomization and had measurements of The change of pulse wave velocity at baseline and from at least one visit after randomization.

Arm/Group Title	Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK)	Felodipine Tablets (Plendil)+Lisinopril (Zestril)	Felodipine Tablet (Plendil)+Hydrochlorothiazide	Felodipine Tablet (Plendil)
Arm/Group Description	Felodipine ER 5mg qd + Metoprolol ER 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Metoprolol 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Metoprolol 95mg qd till the end of the study (week 14).	Felodipine ER 5mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Lisinopril 20mg qd till the end of the study ( week 14).	Felodipine ER 5mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Hydrochlorothiazide 25mg qd till the end of the study (week 14).	Felodipine ER 5mg qd, the patients who didn't achive the target blood pressure (140/90) after 2 weeks (week1 and week2), switch to combination thearapies.
Measure Participants	33	32	35	181
week 2	NA (NA)	NA (NA)	NA (NA)	-0.58 (1.69)
week 14	NA (NA)	NA (NA)	NA (NA)	-0.86 (1.93)

12. Secondary Outcome

Title	The Magnitude of Systolic and Diastolic Blood Pressure Changes From Baseline Among the Subjects Who Reached Target at 2 Weeks of Felodipine Sustained Release, Alone
Description	The duration of the combination therapy was 2 weeks. Blood pressure was measured at week 2 of the trial.
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

The ITT population was defined as all patients who received at least one dose of study drug after randomization and had measurements of blood pressure at baseline and from at least one visit after randomization.

Arm/Group Title	Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK)	Felodipine Tablets (Plendil)+Lisinopril (Zestril)	Felodipine Tablet (Plendil)+Hydrochlorothiazide	Felodipine Tablet (Plendil)
Arm/Group Description	Felodipine ER 5mg qd + Metoprolol ER 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Metoprolol 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Metoprolol 95mg qd till the end of the study (week 14).	Felodipine ER 5mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Lisinopril 20mg qd till the end of the study ( week 14).	Felodipine ER 5mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Hydrochlorothiazide 25mg qd till the end of the study (week 14).	Felodipine ER 5mg qd, the patients who didn't achive the target blood pressure (140/90) after 2 weeks (week1 and week2), switch to combination thearapies.
Measure Participants	84	84	91	208
Change of systolic blood pressure	NA (NA)	NA (NA)	NA (NA)	-22.8 (11.2)
Change of diastolic blood pressure	NA (NA)	NA (NA)	NA (NA)	-15.1 (8.2)

Adverse Events

Arm/Group Title	Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK)		Felodipine Tablets (Plendil)+Lisinopril (Zestril)		Felodipine Tablet (Plendil)+Hydrochlorothiazide		Felodipine Tablet (Plendil)
Arm/Group Description	Felodipine ER 5mg qd + Metoprolol ER 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Metoprolol 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Metoprolol 95mg qd till the end of the study (week 14).		Felodipine ER 5mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Lisinopril 20mg qd till the end of the study ( week 14).		Felodipine ER 5mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Hydrochlorothiazide 25mg qd till the end of the study (week 14).		Felodipine ER 5mg qd, the patients who didn't achive the target blood pressure (140/90) after 2 weeks (week1 and week2), switch to combination thearapies.
All Cause Mortality
	Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK)		Felodipine Tablets (Plendil)+Lisinopril (Zestril)		Felodipine Tablet (Plendil)+Hydrochlorothiazide		Felodipine Tablet (Plendil)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK)		Felodipine Tablets (Plendil)+Lisinopril (Zestril)		Felodipine Tablet (Plendil)+Hydrochlorothiazide		Felodipine Tablet (Plendil)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/85 (0%)		0/85 (0%)		0/92 (0%)		2/260 (0.8%)
Gastrointestinal disorders
Gastrointestinal system damage	0/85 (0%)		0/85 (0%)		0/92 (0%)		1/260 (0.4%)
Nervous system disorders
Nervous system damage	0/85 (0%)		0/85 (0%)		0/92 (0%)		1/260 (0.4%)
Other (Not Including Serious) Adverse Events
	Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK)		Felodipine Tablets (Plendil)+Lisinopril (Zestril)		Felodipine Tablet (Plendil)+Hydrochlorothiazide		Felodipine Tablet (Plendil)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	11/85 (12.9%)		8/85 (9.4%)		9/92 (9.8%)		46/260 (17.7%)
Nervous system disorders
Headache	4/85 (4.7%)		5/85 (5.9%)		4/92 (4.3%)		33/260 (12.7%)
Vascular disorders
Flushing	7/85 (8.2%)		3/85 (3.5%)		5/92 (5.4%)		13/260 (5%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.