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Trial record 4 of 15 for:    Hydrochlorothiazide AND metoprolol succinate

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

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ClinicalTrials.gov Identifier: NCT02336607
Recruitment Status : Completed
First Posted : January 13, 2015
Results First Posted : March 23, 2015
Last Update Posted : March 23, 2015
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label)
Condition Hypertension
Interventions Drug: Felodipine tablet (Plendil) alone
Drug: Felodipine tablet (Plendil)+Hydrochlorothiazide
Drug: Felodipine tablet (Plendil)+Metoprolol tablet (Betaloc ZOK)
Drug: Felodipine tablets (Plendil)+Lisinopril (Zestril)
Enrollment 529
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.
Arm/Group Title Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK) Felodipine Tablets (Plendil)+Lisinopril (Zestril) Felodipine Tablet (Plendil)+Hydrochlorothiazide Felodipine Tablet (Plendil)
Hide 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
Reason Not Completed
Physician Decision             1             4             3             15
Lack of Efficacy             1             0             0             2
Lost to Follow-up             2             1             0             21
Protocol Violation             0             1             1             3
Adverse Event             0             2             2             26
Withdrawal by Subject             0             2             0             20
Arm/Group Title Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK) Felodipine Tablets (Plendil)+Lisinopril (Zestril) Felodipine Tablet (Plendil)+Hydrochlorothiazide Felodipine Tablet (Plendil) Total
Hide 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 Number of Baseline Participants 84 84 91 222 481
Hide Baseline Analysis Population Description
Baseline characteristics are based on ITT group.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 84 participants 84 participants 91 participants 222 participants 481 participants
53.4  (10.8) 55.2  (10.7) 55.6  (9.9) 55  (11.3) 54.9  (10.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 84 participants 84 participants 91 participants 222 participants 481 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%
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.
Hide Description [Not Specified]
Time Frame 14 weeks
Hide Outcome Measure Data
Hide 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)
Hide 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.
Overall Number of Participants Analyzed 78 75 75 181
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage
74.1
(64.5 to 83.6)
80.5
(71.7 to 89.4)
80.2
(71.8 to 88.6)
NA [1] 
(NA to NA)
[1]
Not include in the analysis of primary end point
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.
Hide Description The duration of the combination therapy was 4 weeks. Blood pressure was measured at week 6 of the trial.
Time Frame 4 weeks
Hide Outcome Measure Data
Hide 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)
Hide 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.
Overall Number of Participants Analyzed 83 84 91 193
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage
45.8
(35.1 to 56.5)
59.5
(49 to 70)
46.2
(35.9 to 56.4)
NA [1] 
(NA to NA)
[1]
Not include in the analysis of this end point
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.
Hide Description The duration of the combination therapy was 8 weeks. Blood pressure was measured at week 10 of the trial.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide 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)
Hide 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.
Overall Number of Participants Analyzed 84 81 89 181
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage
78.6
(69.8 to 87.3)
79
(70.1 to 87.9)
78.7
(70.1 to 87.2)
NA [1] 
(NA to NA)
[1]
Not include in the analysis of this end point
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.
Hide Description The duration of the combination therapy was 4 weeks. Blood pressure was measured at week 6 of the trial.
Time Frame 4 weeks
Hide Outcome Measure Data
Hide 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)
Hide 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.
Overall Number of Participants Analyzed 83 84 91 193
Mean (Standard Deviation)
Unit of Measure: mmHg
Change of systolic blood pressure -10.3  (2.0) -13.4  (1.8) -9.8  (1.4) NA [1]   (NA)
Change of diastolic blood pressure -7.3  (1.5) -9.9  (1.4) -6.0  (1.0) NA [1]   (NA)
[1]
Not include in the analysis of this end point
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.
Hide Description The duration of the combination therapy was 8 weeks. Blood pressure was measured at week 10 of the trial.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide 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)
Hide 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.
Overall Number of Participants Analyzed 84 81 89 181
Mean (Standard Deviation)
Unit of Measure: mmHg
Change of systolic blood pressure -17.8  (2.2) -18.0  (1.9) -16.4  (1.5) NA [1]   (NA)
Change of diastolic blood pressure -11.3  (1.3) -12.1  (1.2) -10.7  (0.9) NA [1]   (NA)
[1]
Not include in the analysis of this end point
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.
Hide Description The duration of the combination therapy was 12 weeks. Blood pressure was measured at week 14 of the trial.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide 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)
Hide 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.
Overall Number of Participants Analyzed 81 77 86 181
Mean (Standard Deviation)
Unit of Measure: mmHg
Change of systolic blood pressure -16.6  (2.1) -18.0  (1.9) -16.8  (1.4) NA [1]   (NA)
Change of diastolic blood pressure -10.7  (1.5) -12.8  (1.3) -10.6  (1.0) NA [1]   (NA)
[1]
Not include in the analysis of this end point
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.
Hide Description The duration of the combination therapy was 4 weeks. Blood pressure was measured at week 6 of the trial.
Time Frame 4 weeks
Hide Outcome Measure Data
Hide 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)
Hide 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.
Overall Number of Participants Analyzed 38 50 42 190
Mean (Standard Deviation)
Unit of Measure: mmHg
Change of systolic blood pressure -16.1  (2.2) -17.1  (1.6) -16.4  (1.4) NA [1]   (NA)
Change of diastolic blood pressure -12.3  (1.6) -10.9  (1.2) -8.2  (1.0) NA [1]   (NA)
[1]
Not include in the analysis of this end point
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.
Hide Description The duration of the combination therapy was 8 weeks. Blood pressure was measured at week 10 of the trial.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide 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)
Hide 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.
Overall Number of Participants Analyzed 66 64 70 180
Mean (Standard Deviation)
Unit of Measure: mmHg
Change of systolic blood pressure -19.4  (1.6) -19.7  (1.4) -18.5  (1.1) NA [1]   (NA)
Change of diastolic blood pressure -13.4  (1.1) -13.1  (0.9) -11.5  (0.7) NA [1]   (NA)
[1]
Not include in the analysis of this end point
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.
Hide Description The duration of the combination therapy was 12 weeks. Blood pressure was measured at week 14 of the trial.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide 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)
Hide 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.
Overall Number of Participants Analyzed 60 62 69 176
Mean (Standard Deviation)
Unit of Measure: mmHg
Change of systolic blood pressure -18.4  (1.7) -20.3  (1.5) -18.2  (1.2) NA [1]   (NA)
Change of diastolic blood pressure -13.0  (1.2) -13.6  (1.1) -12.2  (0.8) NA [1]   (NA)
[1]
Not include in the analysis of this end point
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.
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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.
Overall Number of Participants Analyzed 33 32 35 181
Mean (Standard Deviation)
Unit of Measure: m/s
-0.12  (0.27) -0.44  (0.38) -0.06  (0.27) NA [1]   (NA)
[1]
Not include in the analysis of this end point
11.Secondary Outcome
Title The Change of Pulse Wave Velocity From Baseline at 2, 14 Weeks of Felodipine Sustained Release Alone.
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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.
Overall Number of Participants Analyzed 33 32 35 181
Mean (Standard Deviation)
Unit of Measure: m/s
week 2 NA [1]   (NA) NA [1]   (NA) NA [1]   (NA) -0.58  (1.69)
week 14 NA [1]   (NA) NA [1]   (NA) NA [1]   (NA) -0.86  (1.93)
[1]
Not include in the analysis of this end point
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
Hide Description The duration of the combination therapy was 2 weeks. Blood pressure was measured at week 2 of the trial.
Time Frame 2 weeks
Hide Outcome Measure Data
Hide 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)
Hide 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.
Overall Number of Participants Analyzed 84 84 91 208
Mean (Standard Deviation)
Unit of Measure: mmHg
Change of systolic blood pressure NA [1]   (NA) NA [1]   (NA) NA [1]   (NA) -22.8  (11.2)
Change of diastolic blood pressure NA [1]   (NA) NA [1]   (NA) NA [1]   (NA) -15.1  (8.2)
[1]
Not include in the analysis of this end point
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK) Felodipine Tablets (Plendil)+Lisinopril (Zestril) Felodipine Tablet (Plendil)+Hydrochlorothiazide Felodipine Tablet (Plendil)
Hide 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 (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide 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 (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/85 (0.00%)   0/85 (0.00%)   0/92 (0.00%)   2/260 (0.77%) 
Gastrointestinal disorders         
Gastrointestinal system damage * [1]  0/85 (0.00%)  0/85 (0.00%)  0/92 (0.00%)  1/260 (0.38%) 
Nervous system disorders         
Nervous system damage * [1]  0/85 (0.00%)  0/85 (0.00%)  0/92 (0.00%)  1/260 (0.38%) 
*
Indicates events were collected by non-systematic assessment
[1]
Not considered drug related according to the investigator.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK) Felodipine Tablets (Plendil)+Lisinopril (Zestril) Felodipine Tablet (Plendil)+Hydrochlorothiazide Felodipine Tablet (Plendil)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   11/85 (12.94%)   8/85 (9.41%)   9/92 (9.78%)   46/260 (17.69%) 
Nervous system disorders         
Headache   4/85 (4.71%)  5/85 (5.88%)  4/92 (4.35%)  33/260 (12.69%) 
Vascular disorders         
Flushing   7/85 (8.24%)  3/85 (3.53%)  5/92 (5.43%)  13/260 (5.00%) 
Indicates events were collected by systematic assessment
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.
Results Point of Contact
Name/Title: BP of Astrazeneca
Organization: Astrazeneca
Phone: +86 21 60302288
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02336607     History of Changes
Other Study ID Numbers: D4385L00001
First Submitted: November 25, 2014
First Posted: January 13, 2015
Results First Submitted: January 12, 2015
Results First Posted: March 23, 2015
Last Update Posted: March 23, 2015