Trial Outcomes & Findings for Nifedipine (Adalat CR, BAY A1040) High Dose PK/PD Study (NCT NCT00768560)
NCT ID: NCT00768560
Last Updated: 2015-06-08
Results Overview
Changes of sitting SBP and DBP (trough values) from baseline (ie \[trough BP at the end of each period during the double-blind treatment period\] minus \[trough BP at the end of the baseline treatment period\])
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
35 participants
Primary outcome timeframe
Baseline and after 2 weeks treatment
Results posted on
2015-06-08
Participant Flow
47 subjects were recruited from 30 Jan 2008 to 11 May 2008 by 3 centers in Japan.
After a 4-week baseline treatment with Adalat controlled release (CR) 40 mg once daily (OD), 35 subjects were randomized to double-blind treatment and were included in the safety analysis. 34 subjects were included in the analysis of pharmacokinetics, efficacy and demographic data. 1 subject discontinued the study in Period 1 due to adverse event.
Participant milestones
| Measure |
Nifedipine 40 mg OD x 40 mg BID x 80 mg OD for 2 Weeks Each
|
Nifedipine 40 mg OD x 80 mg OD x 40 mg BID for 2 Weeks Each
|
Nifedipine 40 mg BID x 80 mg OD x 40 mg OD for 2 Weeks Each
|
Nifedipine 40 mg BID x 40 mg OD x 80 mg OD for 2 Weeks Each
|
Nifedipine 80 mg OD x 40 mg OD x 40 mg BID for 2 Weeks Each
|
Nifedipine 80 mg OD x 40 mg BID x 40 mg OD for 2 Weeks Each
|
|---|---|---|---|---|---|---|
|
Intervention Set 1
STARTED
|
5
|
6
|
6
|
6
|
6
|
6
|
|
Intervention Set 1
Subjects Received Treatment
|
5
|
6
|
6
|
6
|
6
|
6
|
|
Intervention Set 1
COMPLETED
|
5
|
5
|
6
|
6
|
6
|
6
|
|
Intervention Set 1
NOT COMPLETED
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Intervention Set 2
STARTED
|
5
|
5
|
6
|
6
|
6
|
6
|
|
Intervention Set 2
COMPLETED
|
5
|
5
|
6
|
6
|
6
|
6
|
|
Intervention Set 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Intervention Set 3
STARTED
|
5
|
5
|
6
|
6
|
6
|
6
|
|
Intervention Set 3
COMPLETED
|
5
|
5
|
6
|
6
|
6
|
6
|
|
Intervention Set 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Nifedipine 40 mg OD x 40 mg BID x 80 mg OD for 2 Weeks Each
|
Nifedipine 40 mg OD x 80 mg OD x 40 mg BID for 2 Weeks Each
|
Nifedipine 40 mg BID x 80 mg OD x 40 mg OD for 2 Weeks Each
|
Nifedipine 40 mg BID x 40 mg OD x 80 mg OD for 2 Weeks Each
|
Nifedipine 80 mg OD x 40 mg OD x 40 mg BID for 2 Weeks Each
|
Nifedipine 80 mg OD x 40 mg BID x 40 mg OD for 2 Weeks Each
|
|---|---|---|---|---|---|---|
|
Intervention Set 1
Adverse Event
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Nifedipine (Adalat CR, BAY A1040) High Dose PK/PD Study
Baseline characteristics by cohort
| Measure |
Nifedipine 40 mg OD x 40 mg BID x 80 mg OD for 2 Weeks Each
n=5 Participants
|
Nifedipine 40 mg OD x 80 mg OD x 40 mg BID for 2 Weeks Each
n=5 Participants
|
Nifedipine 40 mg BID x 80 mg OD x 40 mg OD for 2 Weeks Each
n=6 Participants
|
Nifedipine 40 mg BID x 40 mg OD x 80 mg OD for 2 Weeks Each
n=6 Participants
|
Nifedipine 80 mg OD x 40 mg OD x 40 mg BID for 2 Weeks Each
n=6 Participants
|
Nifedipine 80 mg OD x 40 mg BID x 40 mg OD for 2 Weeks Each
n=6 Participants
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
61.4 years
n=93 Participants
|
63.6 years
n=4 Participants
|
59.7 years
n=27 Participants
|
64.3 years
n=483 Participants
|
58.2 years
n=36 Participants
|
59.7 years
n=10 Participants
|
61.1 years
n=115 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
8 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
5 Participants
n=36 Participants
|
5 Participants
n=10 Participants
|
26 Participants
n=115 Participants
|
|
Blood Pressure (Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)) at Baseline
SBP at baseline
|
150.00 mm Hg
STANDARD_DEVIATION 7.91 • n=93 Participants
|
161.00 mm Hg
STANDARD_DEVIATION 16.67 • n=4 Participants
|
156.33 mm Hg
STANDARD_DEVIATION 11.18 • n=27 Participants
|
155.83 mm Hg
STANDARD_DEVIATION 10.96 • n=483 Participants
|
156.33 mm Hg
STANDARD_DEVIATION 14.79 • n=36 Participants
|
154.83 mm Hg
STANDARD_DEVIATION 13.53 • n=10 Participants
|
155.89 mm Hg
STANDARD_DEVIATION 12.38 • n=115 Participants
|
|
Blood Pressure (Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)) at Baseline
DBP at baseline
|
94.40 mm Hg
STANDARD_DEVIATION 4.98 • n=93 Participants
|
95.00 mm Hg
STANDARD_DEVIATION 6.60 • n=4 Participants
|
98.00 mm Hg
STANDARD_DEVIATION 6.45 • n=27 Participants
|
91.00 mm Hg
STANDARD_DEVIATION 7.07 • n=483 Participants
|
92.50 mm Hg
STANDARD_DEVIATION 3.45 • n=36 Participants
|
89.83 mm Hg
STANDARD_DEVIATION 7.68 • n=10 Participants
|
93.43 mm Hg
STANDARD_DEVIATION 6.40 • n=115 Participants
|
|
Heart rate (HR) at Baseline
|
64.20 beats / min
STANDARD_DEVIATION 6.18 • n=93 Participants
|
72.67 beats / min
STANDARD_DEVIATION 13.95 • n=4 Participants
|
79.00 beats / min
STANDARD_DEVIATION 10.81 • n=27 Participants
|
70.83 beats / min
STANDARD_DEVIATION 5.42 • n=483 Participants
|
68.50 beats / min
STANDARD_DEVIATION 7.87 • n=36 Participants
|
79.50 beats / min
STANDARD_DEVIATION 17.84 • n=10 Participants
|
72.69 beats / min
STANDARD_DEVIATION 11.83 • n=115 Participants
|
PRIMARY outcome
Timeframe: Baseline and after 2 weeks treatmentPopulation: Per-protocol efficacy population: subjects valid for safety analysis who have no critical protocol deviation and have trough BP at the end of baseline treatment period and trough BP at the end of period 1 are considered valid for the analysis.
Changes of sitting SBP and DBP (trough values) from baseline (ie \[trough BP at the end of each period during the double-blind treatment period\] minus \[trough BP at the end of the baseline treatment period\])
Outcome measures
| Measure |
Nifedipine (Adalat CR, BAYA1040) 40 mg OD
n=34 Participants
Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) once daily (OD) in the morning
|
Nifedipine (Adalat CR, BAYA1040) 40 mg BID
n=34 Participants
Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) twice daily (BID). 40 mg in the morning and 40 mg in the evening
|
Nifedipine (Adalat CR, BAYA1040) 80 mg OD
n=34 Participants
Nifedipine (Adalat CR, BAYA1040) 80 milligram (mg) once daily (OD) in the morning
|
|---|---|---|---|
|
Change of Sitting Blood Pressure
Systolic Blood Pressure
|
-10.19 mm Hg
Standard Error 1.24
|
-19.88 mm Hg
Standard Error 1.24
|
-10.13 mm Hg
Standard Error 1.24
|
|
Change of Sitting Blood Pressure
Diastolic Blood Pressure
|
-4.30 mm Hg
Standard Error 0.65
|
-8.28 mm Hg
Standard Error 0.65
|
-4.98 mm Hg
Standard Error 0.65
|
SECONDARY outcome
Timeframe: Baseline and after 2 weeks treatmentPopulation: Subjects valid for efficacy analysis
Differences in blood pressure at the same time points (0, 2, 4, 6, 8, 10, 12, 24-hour post-dose) between 2 different days (ie, end of baseline treatment period and end of 2-week treatment period)
Outcome measures
| Measure |
Nifedipine (Adalat CR, BAYA1040) 40 mg OD
n=34 Participants
Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) once daily (OD) in the morning
|
Nifedipine (Adalat CR, BAYA1040) 40 mg BID
n=34 Participants
Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) twice daily (BID). 40 mg in the morning and 40 mg in the evening
|
Nifedipine (Adalat CR, BAYA1040) 80 mg OD
n=34 Participants
Nifedipine (Adalat CR, BAYA1040) 80 milligram (mg) once daily (OD) in the morning
|
|---|---|---|---|
|
Differences of Systolic Blood Pressure Profile
At 0-hour post-dose
|
-11.35 mm Hg
Standard Deviation 15.75
|
-21.24 mm Hg
Standard Deviation 11.56
|
-9.91 mm Hg
Standard Deviation 10.58
|
|
Differences of Systolic Blood Pressure Profile
At 2-hour post-dose
|
-4.91 mm Hg
Standard Deviation 11.62
|
-8.65 mm Hg
Standard Deviation 11.19
|
-11.97 mm Hg
Standard Deviation 10.15
|
|
Differences of Systolic Blood Pressure Profile
At 4-hour post-dose
|
-6.18 mm Hg
Standard Deviation 12.05
|
-5.76 mm Hg
Standard Deviation 11.25
|
-7.85 mm Hg
Standard Deviation 10.02
|
|
Differences of Systolic Blood Pressure Profile
At 6-hour post-dose
|
-6.56 mm Hg
Standard Deviation 12.58
|
-4.94 mm Hg
Standard Deviation 9.31
|
-7.26 mm Hg
Standard Deviation 8.40
|
|
Differences of Systolic Blood Pressure Profile
At 8-hour post-dose
|
-7.88 mm Hg
Standard Deviation 11.53
|
-6.97 mm Hg
Standard Deviation 10.23
|
-7.88 mm Hg
Standard Deviation 10.68
|
|
Differences of Systolic Blood Pressure Profile
At 10-hour post-dose
|
-4.79 mm Hg
Standard Deviation 10.60
|
-4.03 mm Hg
Standard Deviation 10.64
|
-6.56 mm Hg
Standard Deviation 9.41
|
|
Differences of Systolic Blood Pressure Profile
At 12-hour post-dose
|
-5.59 mm Hg
Standard Deviation 10.98
|
-4.38 mm Hg
Standard Deviation 9.31
|
-6.00 mm Hg
Standard Deviation 9.98
|
|
Differences of Systolic Blood Pressure Profile
At 24-hour post-dose
|
-8.97 mm Hg
Standard Deviation 12.79
|
-18.38 mm Hg
Standard Deviation 8.34
|
-10.21 mm Hg
Standard Deviation 10.87
|
SECONDARY outcome
Timeframe: Baseline and after 2 weeks treatmentPopulation: Subjects valid for efficacy analysis
Differences in blood pressure at the same time points (0, 2, 4, 6, 8, 10, 12, 24-hour post-dose) between 2 different days (ie, end of baseline treatment period and end of 2-week treatment period)
Outcome measures
| Measure |
Nifedipine (Adalat CR, BAYA1040) 40 mg OD
n=34 Participants
Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) once daily (OD) in the morning
|
Nifedipine (Adalat CR, BAYA1040) 40 mg BID
n=34 Participants
Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) twice daily (BID). 40 mg in the morning and 40 mg in the evening
|
Nifedipine (Adalat CR, BAYA1040) 80 mg OD
n=34 Participants
Nifedipine (Adalat CR, BAYA1040) 80 milligram (mg) once daily (OD) in the morning
|
|---|---|---|---|
|
Differences of Diastolic Blood Pressure Profile
At 0-hour post-dose
|
-3.82 mm Hg
Standard Deviation 6.40
|
-8.12 mm Hg
Standard Deviation 6.24
|
-4.18 mm Hg
Standard Deviation 5.54
|
|
Differences of Diastolic Blood Pressure Profile
At 2-hour post-dose
|
-4.15 mm Hg
Standard Deviation 7.27
|
-5.47 mm Hg
Standard Deviation 7.01
|
-7.18 mm Hg
Standard Deviation 5.89
|
|
Differences of Diastolic Blood Pressure Profile
At 4-hour post dose
|
-3.44 mm Hg
Standard Deviation 7.47
|
-1.62 mm Hg
Standard Deviation 8.11
|
-3.68 mm Hg
Standard Deviation 6.33
|
|
Differences of Diastolic Blood Pressure Profile
At 6-hour post-dose
|
-5.56 mm Hg
Standard Deviation 7.42
|
-1.71 mm Hg
Standard Deviation 7.20
|
-3.85 mm Hg
Standard Deviation 5.94
|
|
Differences of Diastolic Blood Pressure Profile
At 8-hour post dose
|
-3.09 mm Hg
Standard Deviation 6.13
|
-3.18 mm Hg
Standard Deviation 6.26
|
-4.74 mm Hg
Standard Deviation 6.30
|
|
Differences of Diastolic Blood Pressure Profile
At 10-hour post-dose
|
-2.24 mm Hg
Standard Deviation 6.34
|
-1.74 mm Hg
Standard Deviation 6.42
|
-3.82 mm Hg
Standard Deviation 7.26
|
|
Differences of Diastolic Blood Pressure Profile
At 12-hour post-dose
|
-2.47 mm Hg
Standard Deviation 6.59
|
-2.15 mm Hg
Standard Deviation 7.30
|
-3.15 mm Hg
Standard Deviation 6.97
|
|
Differences of Diastolic Blood Pressure Profile
At 24-hour post dose
|
-5.00 mm Hg
Standard Deviation 7.34
|
-8.47 mm Hg
Standard Deviation 5.39
|
-5.82 mm Hg
Standard Deviation 8.18
|
SECONDARY outcome
Timeframe: After 2 weeks treatmentPopulation: Subjects valid for efficacy analysis
Elderly subjects (≥65 years) without diabetes mellitus or chronic renal disorders and target BP SBP \<140 mm Hg and DBP \<90 mm Hg
Outcome measures
| Measure |
Nifedipine (Adalat CR, BAYA1040) 40 mg OD
n=5 Participants
Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) once daily (OD) in the morning
|
Nifedipine (Adalat CR, BAYA1040) 40 mg BID
n=5 Participants
Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) twice daily (BID). 40 mg in the morning and 40 mg in the evening
|
Nifedipine (Adalat CR, BAYA1040) 80 mg OD
n=5 Participants
Nifedipine (Adalat CR, BAYA1040) 80 milligram (mg) once daily (OD) in the morning
|
|---|---|---|---|
|
Target Blood Pressure Achievement in Elderly (≥65)
|
2 participants
|
3 participants
|
3 participants
|
SECONDARY outcome
Timeframe: After 2 weeks treatmentPopulation: Subjects valid for efficacy analysis
Non-elderly subjects (\<65 years) without diabetes mellitus or chronic renal disorder and target BP SBP \<130 mm Hg and DBP \<85 mm Hg
Outcome measures
| Measure |
Nifedipine (Adalat CR, BAYA1040) 40 mg OD
n=14 Participants
Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) once daily (OD) in the morning
|
Nifedipine (Adalat CR, BAYA1040) 40 mg BID
n=14 Participants
Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) twice daily (BID). 40 mg in the morning and 40 mg in the evening
|
Nifedipine (Adalat CR, BAYA1040) 80 mg OD
n=14 Participants
Nifedipine (Adalat CR, BAYA1040) 80 milligram (mg) once daily (OD) in the morning
|
|---|---|---|---|
|
Target Blood Pressure Achievement in Non-elderly (<65)
|
3 participants
|
10 participants
|
4 participants
|
SECONDARY outcome
Timeframe: After 2 weeks treatmentPopulation: Subjects valid for efficacy analysis
Subjects with diabetes mellitus or chronic renal disorders and target BP SBP \<130 mm Hg and DBP \<80 mm Hg
Outcome measures
| Measure |
Nifedipine (Adalat CR, BAYA1040) 40 mg OD
n=15 Participants
Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) once daily (OD) in the morning
|
Nifedipine (Adalat CR, BAYA1040) 40 mg BID
n=15 Participants
Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) twice daily (BID). 40 mg in the morning and 40 mg in the evening
|
Nifedipine (Adalat CR, BAYA1040) 80 mg OD
n=15 Participants
Nifedipine (Adalat CR, BAYA1040) 80 milligram (mg) once daily (OD) in the morning
|
|---|---|---|---|
|
Target Blood Pressure Achievement in Subjects With Diabetes Mellitus or Chronic Renal Disorder
|
0 participants
|
4 participants
|
1 participants
|
SECONDARY outcome
Timeframe: After 2 weeks treatmentPopulation: Subjects valid for efficacy analysis
Subjects (≥65 years) without diabetes mellitus or chronic renal disorders and target BP SBP \<140 mm Hg and DBP \<90 mm Hg. Subjects (\<65 years) without diabetes mellitus or chronic renal disorder and target BP SBP \<130 mm Hg and DBP \<85 mm Hg. Subjects with diabetes mellitus or chronic renal disorders and target BP SBP \<130 mm Hg and DBP \<80 mm Hg.
Outcome measures
| Measure |
Nifedipine (Adalat CR, BAYA1040) 40 mg OD
n=34 Participants
Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) once daily (OD) in the morning
|
Nifedipine (Adalat CR, BAYA1040) 40 mg BID
n=34 Participants
Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) twice daily (BID). 40 mg in the morning and 40 mg in the evening
|
Nifedipine (Adalat CR, BAYA1040) 80 mg OD
n=34 Participants
Nifedipine (Adalat CR, BAYA1040) 80 milligram (mg) once daily (OD) in the morning
|
|---|---|---|---|
|
Target Blood Pressure Achievement in All Subjects
|
5 participants
|
17 participants
|
8 participants
|
Adverse Events
Nifedipine (Adalat CR, BAYA1040) 40 mg OD
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Nifedipine (Adalat CR, BAYA1040) 40 mg BID
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Nifedipine (Adalat CR, BAYA1040) 80 mg OD
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Nifedipine (Adalat CR, BAYA1040) 40 mg OD
n=35 participants at risk
Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) once daily (OD) in the morning
|
Nifedipine (Adalat CR, BAYA1040) 40 mg BID
n=34 participants at risk
Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) twice daily (BID). 40 mg in the morning and 40 mg in the evening
|
Nifedipine (Adalat CR, BAYA1040) 80 mg OD
n=34 participants at risk
Nifedipine (Adalat CR, BAYA1040) 80 milligram (mg) once daily (OD) in the morning
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
5.7%
2/35
|
0.00%
0/34
|
5.9%
2/34
|
|
Cardiac disorders
Atrial fibrillation
|
2.9%
1/35
|
0.00%
0/34
|
0.00%
0/34
|
|
Gastrointestinal disorders
Stomach discomfort
|
0.00%
0/35
|
2.9%
1/34
|
0.00%
0/34
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/35
|
5.9%
2/34
|
0.00%
0/34
|
|
Investigations
Blood albumin decreased
|
2.9%
1/35
|
2.9%
1/34
|
0.00%
0/34
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/35
|
2.9%
1/34
|
0.00%
0/34
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/35
|
0.00%
0/34
|
2.9%
1/34
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/35
|
2.9%
1/34
|
0.00%
0/34
|
|
Cardiac disorders
Cardiac murmur
|
2.9%
1/35
|
0.00%
0/34
|
0.00%
0/34
|
|
Investigations
Haematocrit decreased
|
0.00%
0/35
|
2.9%
1/34
|
2.9%
1/34
|
|
Investigations
White blood cell count decreased
|
0.00%
0/35
|
0.00%
0/34
|
2.9%
1/34
|
|
Metabolism and nutrition disorders
Lipid metabolism disorder
|
2.9%
1/35
|
2.9%
1/34
|
0.00%
0/34
|
|
Cardiac disorders
Carotid arteriosclerosis
|
0.00%
0/35
|
0.00%
0/34
|
2.9%
1/34
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/35
|
0.00%
0/34
|
2.9%
1/34
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/35
|
0.00%
0/34
|
2.9%
1/34
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/35
|
2.9%
1/34
|
0.00%
0/34
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60