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This is a multi-center, randomized, double-blind, 6 x 3 cross-over study. All patients who meet the entry criteria will be required to stop taking any other anti-hypertensive agents than Adalat CR (controlled release), if taken, before starting 4 weeks (±7days) open-label Adalat CR 40 mg once daily (OD) treatment phase (baseline treatment period). Of them, those who are confirmed with their eligibility as subjects for the present study at the end of the baseline treatment period will be randomly allocated to one of the 6 treatment sequences on the basis of a computer-generated randomization list. Subsequently, BAY A1040 CR tablet 40 mg OD, 40 mg twice daily (BID) or 80 mg OD will be administered to a total of 6 weeks, 2 weeks per each treatment period (Period 1-3) under double-blind conditions using BAY A1040 CR tablet 40 mg and its placebo as follows (Double-blind treatment period).
Issues on safety are addressed in the Adverse Event section.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nifedipine (Adalat CR, BAYA1040) 40 mg OD | Active Comparator | Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) once daily (OD) in the morning |
|
| Nifedipine (Adalat CR, BAYA1040) 40 mg BID | Experimental | 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 | Experimental | Nifedipine (Adalat CR, BAYA1040) 80 milligram (mg) once daily (OD) in the morning |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nifedipine (Adalat CR, BAYA1040) 80mg OD | Drug | Nifedipine (Adalat CR, BAYA1040) 80 milligram (mg) once daily (OD) in the morning |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of Sitting Blood Pressure | 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]) | Baseline and after 2 weeks treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Differences of Systolic Blood Pressure Profile | 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) | Baseline and after 2 weeks treatment |
| Differences of Diastolic Blood Pressure Profile |
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Inclusion Criteria:
Male and female
20 years or older and less than 75 years
Outpatient
Untreated or treated patients with antihypertensive agents whose blood pressure (BP) in sitting position at entry (Visit 1) is as follows.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sendai | Miyagi | 982-0032 | 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.
47 subjects were recruited from 30 Jan 2008 to 11 May 2008 by 3 centers in Japan.
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| ID | Title | Description |
|---|---|---|
| FG000 | Nifedipine 40 mg OD x 40 mg BID x 80 mg OD for 2 Weeks Each | |
| FG001 | Nifedipine 40 mg OD x 80 mg OD x 40 mg BID for 2 Weeks Each | |
| FG002 | Nifedipine 40 mg BID x 80 mg OD x 40 mg OD for 2 Weeks Each | |
| FG003 | Nifedipine 40 mg BID x 40 mg OD x 80 mg OD for 2 Weeks Each | |
| FG004 | Nifedipine 80 mg OD x 40 mg OD x 40 mg BID for 2 Weeks Each | |
| FG005 | Nifedipine 80 mg OD x 40 mg BID x 40 mg OD for 2 Weeks Each |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Intervention Set 1 |
|
| |||||||||||||||||||||
| Intervention Set 2 |
| ||||||||||||||||||||||
| Intervention Set 3 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Nifedipine 40 mg OD x 40 mg BID x 80 mg OD for 2 Weeks Each | |
| BG001 | Nifedipine 40 mg OD x 80 mg OD x 40 mg BID for 2 Weeks Each | |
| BG002 | Nifedipine 40 mg BID x 80 mg OD x 40 mg OD for 2 Weeks Each |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change of Sitting Blood Pressure | 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]) | 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. | Posted | Least Squares Mean | Standard Error | mm Hg | Baseline and after 2 weeks treatment |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nifedipine (Adalat CR, BAYA1040) 40 mg OD | Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) once daily (OD) in the morning |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | BAYER | clinical-trials-contact@bayerhealthcare.com |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D009543 | Nifedipine |
| C494814 | BID protein, human |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Nifedipine (Adalat CR, BAYA1040) 40mg BID | Drug | 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) 40mg OD | Drug | Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) once daily (OD) in the morning |
|
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) |
| Baseline and after 2 weeks treatment |
| Target Blood Pressure Achievement in Elderly (≥65) | Elderly subjects (≥65 years) without diabetes mellitus or chronic renal disorders and target BP SBP <140 mm Hg and DBP <90 mm Hg | After 2 weeks treatment |
| Target Blood Pressure Achievement in Non-elderly (<65) | Non-elderly subjects (<65 years) without diabetes mellitus or chronic renal disorder and target BP SBP <130 mm Hg and DBP <85 mm Hg | After 2 weeks treatment |
| Target Blood Pressure Achievement in Subjects With Diabetes Mellitus or Chronic Renal Disorder | Subjects with diabetes mellitus or chronic renal disorders and target BP SBP <130 mm Hg and DBP <80 mm Hg | After 2 weeks treatment |
| Target Blood Pressure Achievement in All Subjects | 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. | After 2 weeks treatment |
| Suita |
| Osaka |
| 565-0853 |
| Japan |
| Koshigaya | Saitama | 343-0827 | Japan |
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| BG003 | Nifedipine 40 mg BID x 40 mg OD x 80 mg OD for 2 Weeks Each |
| BG004 | Nifedipine 80 mg OD x 40 mg OD x 40 mg BID for 2 Weeks Each |
| BG005 | Nifedipine 80 mg OD x 40 mg BID x 40 mg OD for 2 Weeks Each |
| BG006 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Blood Pressure (Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)) at Baseline | Blood pressure (BP) before the start of baseline treatment. Subjects valid for safety analysis | Mean | Standard Deviation | mm Hg |
|
| Heart rate (HR) at Baseline | Heart rate (HR) before the start of baseline treatment. Subjects valid for safety analysis | Mean | Standard Deviation | beats / min |
|
Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) twice daily (BID). 40 mg in the morning and 40 mg in the evening |
| OG002 | Nifedipine (Adalat CR, BAYA1040) 80 mg OD | Nifedipine (Adalat CR, BAYA1040) 80 milligram (mg) once daily (OD) in the morning |
|
|
|
| Secondary | Differences of Systolic Blood Pressure Profile | 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) | Subjects valid for efficacy analysis | Posted | Mean | Standard Deviation | mm Hg | Baseline and after 2 weeks treatment |
|
|
|
| Secondary | Differences of Diastolic Blood Pressure Profile | 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) | Subjects valid for efficacy analysis | Posted | Mean | Standard Deviation | mm Hg | Baseline and after 2 weeks treatment |
|
|
|
| Secondary | Target Blood Pressure Achievement in Elderly (≥65) | Elderly subjects (≥65 years) without diabetes mellitus or chronic renal disorders and target BP SBP <140 mm Hg and DBP <90 mm Hg | Subjects valid for efficacy analysis | Posted | Number | participants | After 2 weeks treatment |
|
|
|
| Secondary | Target Blood Pressure Achievement in Non-elderly (<65) | Non-elderly subjects (<65 years) without diabetes mellitus or chronic renal disorder and target BP SBP <130 mm Hg and DBP <85 mm Hg | Subjects valid for efficacy analysis | Posted | Number | participants | After 2 weeks treatment |
|
|
|
| Secondary | Target Blood Pressure Achievement in Subjects With Diabetes Mellitus or Chronic Renal Disorder | Subjects with diabetes mellitus or chronic renal disorders and target BP SBP <130 mm Hg and DBP <80 mm Hg | Subjects valid for efficacy analysis | Posted | Number | participants | After 2 weeks treatment |
|
|
|
| Secondary | Target Blood Pressure Achievement in All Subjects | 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. | Subjects valid for efficacy analysis | Posted | Number | participants | After 2 weeks treatment |
|
|
|
| 0 |
| 35 |
| 5 |
| 35 |
| EG001 | Nifedipine (Adalat CR, BAYA1040) 40 mg BID | Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) twice daily (BID). 40 mg in the morning and 40 mg in the evening | 0 | 34 | 7 | 34 |
| EG002 | Nifedipine (Adalat CR, BAYA1040) 80 mg OD | Nifedipine (Adalat CR, BAYA1040) 80 milligram (mg) once daily (OD) in the morning | 0 | 34 | 5 | 34 |
| Atrial fibrillation | Cardiac disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Stomach discomfort | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
|
| Blood albumin decreased | Investigations | MedDRA 11.0 | Non-systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 11.0 | Non-systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 11.0 | Non-systematic Assessment |
|
| Blood triglycerides increased | Investigations | MedDRA 11.0 | Non-systematic Assessment |
|
| Cardiac murmur | Cardiac disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Haematocrit decreased | Investigations | MedDRA 11.0 | Non-systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 11.0 | Non-systematic Assessment |
|
| Lipid metabolism disorder | Metabolism and nutrition disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Carotid arteriosclerosis | Cardiac disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Loss of consciousness | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Nocturia | Renal and urinary disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Swelling face | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
|
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| At 4-hour post-dose |
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| At 6-hour post-dose |
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| At 8-hour post-dose |
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| At 10-hour post-dose |
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| At 12-hour post-dose |
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| At 24-hour post-dose |
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| At 4-hour post dose |
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| At 6-hour post-dose |
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| At 8-hour post dose |
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| At 10-hour post-dose |
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| At 12-hour post-dose |
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| At 24-hour post dose |
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