Hypertension
Conditions
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.
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.
Interventions
DRUGFelodipine 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).
DRUGFelodipine 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.
DRUGFelodipine 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.
DRUGFelodipine 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
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to 79 Years
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
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 details
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.
Participants by arm
| Arm | Count |
|---|---|
| Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK) 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). | 84 |
| Felodipine Tablets (Plendil)+Lisinopril (Zestril) 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). | 84 |
| Felodipine Tablet (Plendil)+Hydrochlorothiazide 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). | 91 |
| Felodipine Tablet (Plendil) 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. | 222 |
| Total | 481 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 2 | 2 | 26 |
| Overall Study | Lack of Efficacy | 1 | 0 | 0 | 2 |
| Overall Study | Lost to Follow-up | 2 | 1 | 0 | 21 |
| Overall Study | Physician Decision | 1 | 4 | 3 | 15 |
| Overall Study | Protocol Violation | 0 | 1 | 1 | 3 |
| Overall Study | Withdrawal by Subject | 0 | 2 | 0 | 20 |
Baseline characteristics
| Characteristic | Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK) | Felodipine Tablets (Plendil)+Lisinopril (Zestril) | Felodipine Tablet (Plendil)+Hydrochlorothiazide | Felodipine Tablet (Plendil) | Total |
|---|---|---|---|---|---|
| Age, Continuous | 53.4 Years STANDARD_DEVIATION 10.8 | 55.2 Years STANDARD_DEVIATION 10.7 | 55.6 Years STANDARD_DEVIATION 9.9 | 55 Years STANDARD_DEVIATION 11.3 | 54.9 Years STANDARD_DEVIATION 10.8 |
| Sex: Female, Male Female | 35 Participants | 35 Participants | 35 Participants | 110 Participants | 215 Participants |
| Sex: Female, Male Male | 49 Participants | 49 Participants | 56 Participants | 112 Participants | 266 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 11 / 85 | 8 / 85 | 9 / 92 | 46 / 260 |
| serious Total, serious adverse events | 0 / 85 | 0 / 85 | 0 / 92 | 2 / 260 |
Outcome results
Primary
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
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK) | 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. | 74.1 Percentage |
| Felodipine Tablets (Plendil)+Lisinopril (Zestril) | 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. | 80.5 Percentage |
| Felodipine Tablet (Plendil)+Hydrochlorothiazide | 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. | 80.2 Percentage |
| Felodipine Tablet (Plendil) | 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. | NA Percentage |
Secondary
The Change of Pulse Wave Velocity at 12 Weeks Compare With Baseline Data of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide.
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
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK) | The Change of Pulse Wave Velocity at 12 Weeks Compare With Baseline Data of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide. | -0.12 m/s | Standard Deviation 0.27 |
| Felodipine Tablets (Plendil)+Lisinopril (Zestril) | The Change of Pulse Wave Velocity at 12 Weeks Compare With Baseline Data of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide. | -0.44 m/s | Standard Deviation 0.38 |
| Felodipine Tablet (Plendil)+Hydrochlorothiazide | The Change of Pulse Wave Velocity at 12 Weeks Compare With Baseline Data of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide. | -0.06 m/s | Standard Deviation 0.27 |
| Felodipine Tablet (Plendil) | The Change of Pulse Wave Velocity at 12 Weeks Compare With Baseline Data of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide. | NA m/s | — |
Secondary
The Change of Pulse Wave Velocity From Baseline at 2, 14 Weeks of Felodipine Sustained Release Alone.
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK) | The Change of Pulse Wave Velocity From Baseline at 2, 14 Weeks of Felodipine Sustained Release Alone. | week 2 | NA m/s | — |
| Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK) | The Change of Pulse Wave Velocity From Baseline at 2, 14 Weeks of Felodipine Sustained Release Alone. | week 14 | NA m/s | — |
| Felodipine Tablets (Plendil)+Lisinopril (Zestril) | The Change of Pulse Wave Velocity From Baseline at 2, 14 Weeks of Felodipine Sustained Release Alone. | week 14 | NA m/s | — |
| Felodipine Tablets (Plendil)+Lisinopril (Zestril) | The Change of Pulse Wave Velocity From Baseline at 2, 14 Weeks of Felodipine Sustained Release Alone. | week 2 | NA m/s | — |
| Felodipine Tablet (Plendil)+Hydrochlorothiazide | The Change of Pulse Wave Velocity From Baseline at 2, 14 Weeks of Felodipine Sustained Release Alone. | week 14 | NA m/s | — |
| Felodipine Tablet (Plendil)+Hydrochlorothiazide | The Change of Pulse Wave Velocity From Baseline at 2, 14 Weeks of Felodipine Sustained Release Alone. | week 2 | NA m/s | — |
| Felodipine Tablet (Plendil) | The Change of Pulse Wave Velocity From Baseline at 2, 14 Weeks of Felodipine Sustained Release Alone. | week 2 | -0.58 m/s | Standard Deviation 1.69 |
| Felodipine Tablet (Plendil) | The Change of Pulse Wave Velocity From Baseline at 2, 14 Weeks of Felodipine Sustained Release Alone. | week 14 | -0.86 m/s | Standard Deviation 1.93 |
Secondary
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.
The duration of the combination therapy was 4 weeks. Blood pressure was measured at week 6 of the trial.
Time frame: 4 weeks
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK) | 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. | Change of systolic blood pressure | -10.3 mmHg | Standard Deviation 2 |
| Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK) | 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. | Change of diastolic blood pressure | -7.3 mmHg | Standard Deviation 1.5 |
| Felodipine Tablets (Plendil)+Lisinopril (Zestril) | 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. | Change of diastolic blood pressure | -9.9 mmHg | Standard Deviation 1.4 |
| Felodipine Tablets (Plendil)+Lisinopril (Zestril) | 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. | Change of systolic blood pressure | -13.4 mmHg | Standard Deviation 1.8 |
| Felodipine Tablet (Plendil)+Hydrochlorothiazide | 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. | Change of systolic blood pressure | -9.8 mmHg | Standard Deviation 1.4 |
| Felodipine Tablet (Plendil)+Hydrochlorothiazide | 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. | Change of diastolic blood pressure | -6.0 mmHg | Standard Deviation 1 |
| Felodipine Tablet (Plendil) | 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. | Change of systolic blood pressure | NA mmHg | — |
| Felodipine Tablet (Plendil) | 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. | Change of diastolic blood pressure | NA mmHg | — |
Secondary
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.
The duration of the combination therapy was 12 weeks. Blood pressure was measured at week 14 of the trial.
Time frame: 12 weeks
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK) | 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. | Change of systolic blood pressure | -16.6 mmHg | Standard Deviation 2.1 |
| Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK) | 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. | Change of diastolic blood pressure | -10.7 mmHg | Standard Deviation 1.5 |
| Felodipine Tablets (Plendil)+Lisinopril (Zestril) | 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. | Change of diastolic blood pressure | -12.8 mmHg | Standard Deviation 1.3 |
| Felodipine Tablets (Plendil)+Lisinopril (Zestril) | 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. | Change of systolic blood pressure | -18.0 mmHg | Standard Deviation 1.9 |
| Felodipine Tablet (Plendil)+Hydrochlorothiazide | 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. | Change of systolic blood pressure | -16.8 mmHg | Standard Deviation 1.4 |
| Felodipine Tablet (Plendil)+Hydrochlorothiazide | 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. | Change of diastolic blood pressure | -10.6 mmHg | Standard Deviation 1 |
| Felodipine Tablet (Plendil) | 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. | Change of systolic blood pressure | NA mmHg | — |
| Felodipine Tablet (Plendil) | 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. | Change of diastolic blood pressure | NA mmHg | — |
Secondary
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.
The duration of the combination therapy was 8 weeks. Blood pressure was measured at week 10 of the trial.
Time frame: 8 weeks
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK) | 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. | Change of systolic blood pressure | -17.8 mmHg | Standard Deviation 2.2 |
| Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK) | 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. | Change of diastolic blood pressure | -11.3 mmHg | Standard Deviation 1.3 |
| Felodipine Tablets (Plendil)+Lisinopril (Zestril) | 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. | Change of diastolic blood pressure | -12.1 mmHg | Standard Deviation 1.2 |
| Felodipine Tablets (Plendil)+Lisinopril (Zestril) | 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. | Change of systolic blood pressure | -18.0 mmHg | Standard Deviation 1.9 |
| Felodipine Tablet (Plendil)+Hydrochlorothiazide | 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. | Change of systolic blood pressure | -16.4 mmHg | Standard Deviation 1.5 |
| Felodipine Tablet (Plendil)+Hydrochlorothiazide | 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. | Change of diastolic blood pressure | -10.7 mmHg | Standard Deviation 0.9 |
| Felodipine Tablet (Plendil) | 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. | Change of systolic blood pressure | NA mmHg | — |
| Felodipine Tablet (Plendil) | 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. | Change of diastolic blood pressure | NA mmHg | — |
Secondary
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.
The duration of the combination therapy was 8 weeks. Blood pressure was measured at week 10 of the trial.
Time frame: 8 weeks
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK) | 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. | Change of systolic blood pressure | -19.4 mmHg | Standard Deviation 1.6 |
| Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK) | 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. | Change of diastolic blood pressure | -13.4 mmHg | Standard Deviation 1.1 |
| Felodipine Tablets (Plendil)+Lisinopril (Zestril) | 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. | Change of diastolic blood pressure | -13.1 mmHg | Standard Deviation 0.9 |
| Felodipine Tablets (Plendil)+Lisinopril (Zestril) | 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. | Change of systolic blood pressure | -19.7 mmHg | Standard Deviation 1.4 |
| Felodipine Tablet (Plendil)+Hydrochlorothiazide | 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. | Change of systolic blood pressure | -18.5 mmHg | Standard Deviation 1.1 |
| Felodipine Tablet (Plendil)+Hydrochlorothiazide | 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. | Change of diastolic blood pressure | -11.5 mmHg | Standard Deviation 0.7 |
| Felodipine Tablet (Plendil) | 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. | Change of systolic blood pressure | NA mmHg | — |
| Felodipine Tablet (Plendil) | 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. | Change of diastolic blood pressure | NA mmHg | — |
Secondary
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.
The duration of the combination therapy was 12 weeks. Blood pressure was measured at week 14 of the trial.
Time frame: 12 weeks
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK) | 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. | Change of systolic blood pressure | -18.4 mmHg | Standard Deviation 1.7 |
| Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK) | 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. | Change of diastolic blood pressure | -13.0 mmHg | Standard Deviation 1.2 |
| Felodipine Tablets (Plendil)+Lisinopril (Zestril) | 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. | Change of diastolic blood pressure | -13.6 mmHg | Standard Deviation 1.1 |
| Felodipine Tablets (Plendil)+Lisinopril (Zestril) | 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. | Change of systolic blood pressure | -20.3 mmHg | Standard Deviation 1.5 |
| Felodipine Tablet (Plendil)+Hydrochlorothiazide | 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. | Change of systolic blood pressure | -18.2 mmHg | Standard Deviation 1.2 |
| Felodipine Tablet (Plendil)+Hydrochlorothiazide | 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. | Change of diastolic blood pressure | -12.2 mmHg | Standard Deviation 0.8 |
| Felodipine Tablet (Plendil) | 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. | Change of systolic blood pressure | NA mmHg | — |
| Felodipine Tablet (Plendil) | 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. | Change of diastolic blood pressure | NA mmHg | — |
Secondary
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
The duration of the combination therapy was 2 weeks. Blood pressure was measured at week 2 of the trial.
Time frame: 2 weeks
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK) | 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 | Change of systolic blood pressure | NA mmHg | — |
| Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK) | 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 | Change of diastolic blood pressure | NA mmHg | — |
| Felodipine Tablets (Plendil)+Lisinopril (Zestril) | 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 | Change of diastolic blood pressure | NA mmHg | — |
| Felodipine Tablets (Plendil)+Lisinopril (Zestril) | 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 | Change of systolic blood pressure | NA mmHg | — |
| Felodipine Tablet (Plendil)+Hydrochlorothiazide | 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 | Change of systolic blood pressure | NA mmHg | — |
| Felodipine Tablet (Plendil)+Hydrochlorothiazide | 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 | Change of diastolic blood pressure | NA mmHg | — |
| Felodipine Tablet (Plendil) | 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 | Change of systolic blood pressure | -22.8 mmHg | Standard Deviation 11.2 |
| Felodipine Tablet (Plendil) | 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 | Change of diastolic blood pressure | -15.1 mmHg | Standard Deviation 8.2 |
Secondary
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.
The duration of the combination therapy was 4 weeks. Blood pressure was measured at week 6 of the trial.
Time frame: 4 weeks
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK) | 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. | Change of systolic blood pressure | -16.1 mmHg | Standard Deviation 2.2 |
| Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK) | 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. | Change of diastolic blood pressure | -12.3 mmHg | Standard Deviation 1.6 |
| Felodipine Tablets (Plendil)+Lisinopril (Zestril) | 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. | Change of diastolic blood pressure | -10.9 mmHg | Standard Deviation 1.2 |
| Felodipine Tablets (Plendil)+Lisinopril (Zestril) | 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. | Change of systolic blood pressure | -17.1 mmHg | Standard Deviation 1.6 |
| Felodipine Tablet (Plendil)+Hydrochlorothiazide | 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. | Change of systolic blood pressure | -16.4 mmHg | Standard Deviation 1.4 |
| Felodipine Tablet (Plendil)+Hydrochlorothiazide | 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. | Change of diastolic blood pressure | -8.2 mmHg | Standard Deviation 1 |
| Felodipine Tablet (Plendil) | 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. | Change of systolic blood pressure | NA mmHg | — |
| Felodipine Tablet (Plendil) | 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. | Change of diastolic blood pressure | NA mmHg | — |
Secondary
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.
The duration of the combination therapy was 4 weeks. Blood pressure was measured at week 6 of the trial.
Time frame: 4 weeks
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK) | 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. | 45.8 Percentage |
| Felodipine Tablets (Plendil)+Lisinopril (Zestril) | 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. | 59.5 Percentage |
| Felodipine Tablet (Plendil)+Hydrochlorothiazide | 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. | 46.2 Percentage |
| Felodipine Tablet (Plendil) | 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. | NA Percentage |
Secondary
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.
The duration of the combination therapy was 8 weeks. Blood pressure was measured at week 10 of the trial.
Time frame: 8 weeks
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK) | 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. | 78.6 Percentage |
| Felodipine Tablets (Plendil)+Lisinopril (Zestril) | 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. | 79 Percentage |
| Felodipine Tablet (Plendil)+Hydrochlorothiazide | 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. | 78.7 Percentage |
| Felodipine Tablet (Plendil) | 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. | NA Percentage |