An interventional study of Felodipine tablet (Plendil) alone and Felodipine tablet (Plendil)+Hydrochlorothiazide in Hypertension, sponsored by AstraZeneca. Completed. Open to participants aged 35 Years to 79 Years. Per ClinicalTrials.gov, last updated 2015-03-23.
Sponsored by AstraZeneca · Not applicable and Interventional
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.
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.
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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, 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:
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:
Drug: Felodipine tablet (Plendil) alone
Drug: Felodipine tablet (Plendil)+Metoprolol tablet (Betaloc ZOK)
Drug: Felodipine tablets (Plendil)+Lisinopril (Zestril)
Drug: Felodipine tablet (Plendil)+Hydrochlorothiazide
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).
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.
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.
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.
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
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
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
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
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
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
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
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
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
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
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
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
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).
| Milestone | Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK) | Felodipine Tablets (Plendil)+Lisinopril (Zestril) | Felodipine Tablet (Plendil)+Hydrochlorothiazide | Felodipine Tablet (Plendil) |
|---|---|---|---|---|
| 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 |
| Withdrew: Physician decision | 1 | 4 | 3 | 15 |
| Withdrew: Lack of efficacy | 1 | 0 | 0 | 2 |
| Withdrew: Lost to follow-up | 2 | 1 | 0 | 21 |
| Withdrew: Protocol violation | 0 | 1 | 1 | 3 |
| Withdrew: Adverse event | 0 | 2 | 2 | 26 |
| Withdrew: Withdrawal by subject | 0 | 2 | 0 | 20 |
| Percentage | Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK) | Felodipine Tablets (Plendil)+Lisinopril (Zestril) | Felodipine Tablet (Plendil)+Hydrochlorothiazide | 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. | 74.1 (64.5 to 83.6) | 80.5 (71.7 to 89.4) | 80.2 (71.8 to 88.6) | NA (NA to NA) |
The duration of the combination therapy was 4 weeks. Blood pressure was measured at week 6 of the trial.
| Percentage | Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK) | Felodipine Tablets (Plendil)+Lisinopril (Zestril) | Felodipine Tablet (Plendil)+Hydrochlorothiazide | 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. | 45.8 (35.1 to 56.5) | 59.5 (49 to 70) | 46.2 (35.9 to 56.4) | NA (NA to NA) |
The duration of the combination therapy was 8 weeks. Blood pressure was measured at week 10 of the trial.
| Percentage | Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK) | Felodipine Tablets (Plendil)+Lisinopril (Zestril) | Felodipine Tablet (Plendil)+Hydrochlorothiazide | 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. | 78.6 (69.8 to 87.3) | 79 (70.1 to 87.9) | 78.7 (70.1 to 87.2) | NA (NA to NA) |
The duration of the combination therapy was 4 weeks. Blood pressure was measured at week 6 of the trial.
| mmHg | Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK) | Felodipine Tablets (Plendil)+Lisinopril (Zestril) | Felodipine Tablet (Plendil)+Hydrochlorothiazide | Felodipine Tablet (Plendil) |
|---|---|---|---|---|
| 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 |
The duration of the combination therapy was 8 weeks. Blood pressure was measured at week 10 of the trial.
| mmHg | Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK) | Felodipine Tablets (Plendil)+Lisinopril (Zestril) | Felodipine Tablet (Plendil)+Hydrochlorothiazide | Felodipine Tablet (Plendil) |
|---|---|---|---|---|
| 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 |
The duration of the combination therapy was 12 weeks. Blood pressure was measured at week 14 of the trial.
| mmHg | Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK) | Felodipine Tablets (Plendil)+Lisinopril (Zestril) | Felodipine Tablet (Plendil)+Hydrochlorothiazide | Felodipine Tablet (Plendil) |
|---|---|---|---|---|
| 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 |
The duration of the combination therapy was 4 weeks. Blood pressure was measured at week 6 of the trial.
| mmHg | Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK) | Felodipine Tablets (Plendil)+Lisinopril (Zestril) | Felodipine Tablet (Plendil)+Hydrochlorothiazide | Felodipine Tablet (Plendil) |
|---|---|---|---|---|
| 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 |
The duration of the combination therapy was 8 weeks. Blood pressure was measured at week 10 of the trial.
| mmHg | Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK) | Felodipine Tablets (Plendil)+Lisinopril (Zestril) | Felodipine Tablet (Plendil)+Hydrochlorothiazide | Felodipine Tablet (Plendil) |
|---|---|---|---|---|
| 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 |
The duration of the combination therapy was 12 weeks. Blood pressure was measured at week 14 of the trial.
| mmHg | Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK) | Felodipine Tablets (Plendil)+Lisinopril (Zestril) | Felodipine Tablet (Plendil)+Hydrochlorothiazide | Felodipine Tablet (Plendil) |
|---|---|---|---|---|
| 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 |
The duration of the combination therapy was 12 weeks. The change of pulse wave velocity was measured at week 14 of the trial.
| m/s | Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK) | Felodipine Tablets (Plendil)+Lisinopril (Zestril) | Felodipine Tablet (Plendil)+Hydrochlorothiazide | 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. | -0.12 ± 0.27 | -0.44 ± 0.38 | -0.06 ± 0.27 | NA ± NA |
The duration of the combination therapy was 12 weeks. The change of pulse wave velocity was measured at week 14 of the trial.
| m/s | Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK) | Felodipine Tablets (Plendil)+Lisinopril (Zestril) | Felodipine Tablet (Plendil)+Hydrochlorothiazide | Felodipine Tablet (Plendil) |
|---|---|---|---|---|
| week 2 | NA ± NA | NA ± NA | NA ± NA | -0.58 ± 1.69 |
| week 14 | NA ± NA | NA ± NA | NA ± NA | -0.86 ± 1.93 |
The duration of the combination therapy was 2 weeks. Blood pressure was measured at week 2 of the trial.
| mmHg | Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK) | Felodipine Tablets (Plendil)+Lisinopril (Zestril) | Felodipine Tablet (Plendil)+Hydrochlorothiazide | Felodipine Tablet (Plendil) |
|---|---|---|---|---|
| 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 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK) | — | 0/85 (0%) | 11/85 (12.9%) |
| Felodipine Tablets (Plendil)+Lisinopril (Zestril) | — | 0/85 (0%) | 8/85 (9.4%) |
| Felodipine Tablet (Plendil)+Hydrochlorothiazide | — | 0/92 (0%) | 9/92 (9.8%) |
| Felodipine Tablet (Plendil) | — | 2/260 (0.8%) | 46/260 (17.7%) |
| Event | Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK) | Felodipine Tablets (Plendil)+Lisinopril (Zestril) | Felodipine Tablet (Plendil)+Hydrochlorothiazide | Felodipine Tablet (Plendil) |
|---|---|---|---|---|
| Gastrointestinal system damageGastrointestinal disorders | 0/85 | 0/85 | 0/92 | 1/260 |
| Nervous system damageNervous system disorders | 0/85 | 0/85 | 0/92 | 1/260 |
| Event | Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK) | Felodipine Tablets (Plendil)+Lisinopril (Zestril) | Felodipine Tablet (Plendil)+Hydrochlorothiazide | Felodipine Tablet (Plendil) |
|---|---|---|---|---|
| HeadacheNervous system disorders | 4/85 | 5/85 | 4/92 | 33/260 |
| FlushingVascular disorders | 7/85 | 3/85 | 5/92 | 13/260 |
Baseline characteristics are based on ITT group.
| Age, Continuous(Years) | Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK) | Felodipine Tablets (Plendil)+Lisinopril (Zestril) | Felodipine Tablet (Plendil)+Hydrochlorothiazide | Felodipine Tablet (Plendil) | Total |
|---|---|---|---|---|---|
| Mean | 53.4 ± 10.8 | 55.2 ± 10.7 | 55.6 ± 9.9 | 55 ± 11.3 | 54.9 ± 10.8 |
| Sex: Female, Male(Participants) | Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK) | Felodipine Tablets (Plendil)+Lisinopril (Zestril) | Felodipine Tablet (Plendil)+Hydrochlorothiazide | Felodipine Tablet (Plendil) | Total |
|---|---|---|---|---|---|
| Female | 35 | 35 | 35 | 110 | 215 |
| Male | 49 | 49 | 56 | 112 | 266 |
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