Trial Outcomes & Findings for Open-Label Long-Term Safety and Efficacy Study of Fixed Dose Combination of Nifedipine Gastrointestinal Therapeutic System and Candesartan Cilexetil in Subjects With Moderate to Severe Essential Hypertension (NCT NCT01788358)
NCT ID: NCT01788358
Last Updated: 2017-10-24
Results Overview
An adverse event (AE) is any untoward medical occurrence (that is, any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study. AEs were considered to be treatment-emergent if they had started or worsened after first application of study medication.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
508 participants
Primary outcome timeframe
From the time of first study drug administration up to Week 28
Results posted on
2017-10-24
Participant Flow
The study was conducted at 70 study centers between 14 February 2013 (first subject first visit) and 1 May 2014 (last subject last visit).
Of 753 subjects screened, 245 subjects were not enrolled, due to screen failure for 215 subjects, consent withdrawal by 23 subjects, protocol violation by 5 subjects, 1 subject was lost to follow-up and recruitment stopped for 1 subject. Remaining 508 subjects were enrolled and received at least 1 treatment with study drug.
Participant milestones
| Measure |
Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106)
Subjects received nifedipine gastrointestinal therapeutic system (GITS) / candesartan cilexetil fixed dose combination (FDC) (BAY98-7106) tablet orally, once daily in the morning of Visit 1 (Week 0) for 28 or 52 weeks. The starting dose (30/8 milligram \[mg\] or 30/16 mg) was determined based on local practice and clinical judgment by the investigator. Based on the experience of symptomatic and asymptomatic hypotension, peripheral edema or significant tolerability, the doses were up-titrated to the highest target dose (60/32 mg).
|
|---|---|
|
Overall Study
STARTED
|
508
|
|
Overall Study
Treated
|
508
|
|
Overall Study
Completed Week 28
|
417
|
|
Overall Study
Entered Extension to Week 52
|
200
|
|
Overall Study
Completed Week 52
|
193
|
|
Overall Study
COMPLETED
|
410
|
|
Overall Study
NOT COMPLETED
|
98
|
Reasons for withdrawal
| Measure |
Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106)
Subjects received nifedipine gastrointestinal therapeutic system (GITS) / candesartan cilexetil fixed dose combination (FDC) (BAY98-7106) tablet orally, once daily in the morning of Visit 1 (Week 0) for 28 or 52 weeks. The starting dose (30/8 milligram \[mg\] or 30/16 mg) was determined based on local practice and clinical judgment by the investigator. Based on the experience of symptomatic and asymptomatic hypotension, peripheral edema or significant tolerability, the doses were up-titrated to the highest target dose (60/32 mg).
|
|---|---|
|
Overall Study
Other
|
11
|
|
Overall Study
Logistical difficulties
|
1
|
|
Overall Study
Lost to Follow-up
|
5
|
|
Overall Study
Protocol Violation
|
3
|
|
Overall Study
Withdrawal by Subject
|
26
|
|
Overall Study
Lack of Efficacy
|
1
|
|
Overall Study
Adverse Event
|
51
|
Baseline Characteristics
Open-Label Long-Term Safety and Efficacy Study of Fixed Dose Combination of Nifedipine Gastrointestinal Therapeutic System and Candesartan Cilexetil in Subjects With Moderate to Severe Essential Hypertension
Baseline characteristics by cohort
| Measure |
Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106)
n=508 Participants
Subjects received nifedipine gastrointestinal therapeutic system (GITS) / candesartan cilexetil fixed dose combination (FDC) (BAY98-7106) tablet orally, once daily in the morning of Visit 1 (Week 0) for 28 or 52 weeks. The starting dose (30/8 milligram \[mg\] or 30/16 mg) was determined based on local practice and clinical judgment by the investigator. Based on the experience of symptomatic and asymptomatic hypotension, peripheral edema or significant tolerability, the doses were up-titrated to the highest target dose (60/32 mg).
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|---|---|
|
Age, Continuous
|
59 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
186 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
322 Participants
n=5 Participants
|
|
Systolic blood pressure
|
170.7 millimeter of mercury (mmHg)
STANDARD_DEVIATION 8.9 • n=5 Participants
|
|
Diastolic blood pressure
|
95.6 mmHg
STANDARD_DEVIATION 10.4 • n=5 Participants
|
PRIMARY outcome
Timeframe: From the time of first study drug administration up to Week 28Population: Safety Analysis Set (SAF): All the subjects enrolled into the open-label treatment period and took at least one unit of the study medication.
An adverse event (AE) is any untoward medical occurrence (that is, any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study. AEs were considered to be treatment-emergent if they had started or worsened after first application of study medication.
Outcome measures
| Measure |
Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106)
n=508 Participants
Subjects received nifedipine gastrointestinal therapeutic system (GITS) / candesartan cilexetil fixed dose combination (FDC) (BAY98-7106) tablet orally, once daily in the morning of Visit 1 (Week 0) for 28 or 52 weeks. The starting dose (30/8 milligram \[mg\] or 30/16 mg) was determined based on local practice and clinical judgment by the investigator. Based on the experience of symptomatic and asymptomatic hypotension, peripheral edema or significant tolerability, the doses were up-titrated to the highest target dose (60/32 mg).
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|---|---|
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Number of Subjects With All Treatment-emergent Adverse Events (TEAEs) and Drug-related TEAEs up to Week 28
All TEAEs
|
390 Subjects
|
|
Number of Subjects With All Treatment-emergent Adverse Events (TEAEs) and Drug-related TEAEs up to Week 28
Drug-related TEAEs
|
230 Subjects
|
PRIMARY outcome
Timeframe: From the time of first study drug administration up to Week 28Population: SAF
An AE is any untoward medical occurrence (that is, any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study. AEs were considered to be treatment-emergent if they had started or worsened after first application of study medication. TEAEs of special interest included the incidence of symptomatic hypotension and the incidence and severity of vasodilatory adverse events (such as oedema, headache, and flushing). Only subjects who had TEAEs of special interest as mild, moderate or severe were reported.
Outcome measures
| Measure |
Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106)
n=508 Participants
Subjects received nifedipine gastrointestinal therapeutic system (GITS) / candesartan cilexetil fixed dose combination (FDC) (BAY98-7106) tablet orally, once daily in the morning of Visit 1 (Week 0) for 28 or 52 weeks. The starting dose (30/8 milligram \[mg\] or 30/16 mg) was determined based on local practice and clinical judgment by the investigator. Based on the experience of symptomatic and asymptomatic hypotension, peripheral edema or significant tolerability, the doses were up-titrated to the highest target dose (60/32 mg).
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|---|---|
|
Number of Subjects With Treatment-emergent Adverse Events (TEAEs) of Special Interest up to Week 28
Oedema (mild)
|
124 Subjects
|
|
Number of Subjects With Treatment-emergent Adverse Events (TEAEs) of Special Interest up to Week 28
Oedema (moderate)
|
54 Subjects
|
|
Number of Subjects With Treatment-emergent Adverse Events (TEAEs) of Special Interest up to Week 28
Oedema (severe)
|
7 Subjects
|
|
Number of Subjects With Treatment-emergent Adverse Events (TEAEs) of Special Interest up to Week 28
Headache (mild)
|
31 Subjects
|
|
Number of Subjects With Treatment-emergent Adverse Events (TEAEs) of Special Interest up to Week 28
Headache (moderate)
|
15 Subjects
|
|
Number of Subjects With Treatment-emergent Adverse Events (TEAEs) of Special Interest up to Week 28
Flushing (mild)
|
3 Subjects
|
|
Number of Subjects With Treatment-emergent Adverse Events (TEAEs) of Special Interest up to Week 28
Symptomatic hypotension (mild)
|
4 Subjects
|
PRIMARY outcome
Timeframe: From the time of first study drug administration up to Week 52/EOSPopulation: SAF
An AE is any untoward medical occurrence (that is, any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study. AEs were considered to be treatment-emergent if they had started or worsened after first application of study medication.
Outcome measures
| Measure |
Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106)
n=508 Participants
Subjects received nifedipine gastrointestinal therapeutic system (GITS) / candesartan cilexetil fixed dose combination (FDC) (BAY98-7106) tablet orally, once daily in the morning of Visit 1 (Week 0) for 28 or 52 weeks. The starting dose (30/8 milligram \[mg\] or 30/16 mg) was determined based on local practice and clinical judgment by the investigator. Based on the experience of symptomatic and asymptomatic hypotension, peripheral edema or significant tolerability, the doses were up-titrated to the highest target dose (60/32 mg).
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|---|---|
|
Number of Subjects With All Treatment-emergent Adverse Events (TEAEs) and Drug-related TEAEs up to Week 52/End of Study (EOS)
All TEAEs
|
404 Subjects
|
|
Number of Subjects With All Treatment-emergent Adverse Events (TEAEs) and Drug-related TEAEs up to Week 52/End of Study (EOS)
Drug-related TEAEs
|
238 Subjects
|
PRIMARY outcome
Timeframe: From the time of study treatment up to Week 52/EOSPopulation: SAF
An AE is any untoward medical occurrence (that is, any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study. AEs were considered to be treatment-emergent if they had started or worsened after first application of study medication. TEAEs of special interest included the incidence of symptomatic hypotension and the incidence and severity of vasodilatory adverse events (such as oedema, headache, and flushing). Only subjects who had TEAEs of special interest as mild, moderate or severe were reported.
Outcome measures
| Measure |
Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106)
n=508 Participants
Subjects received nifedipine gastrointestinal therapeutic system (GITS) / candesartan cilexetil fixed dose combination (FDC) (BAY98-7106) tablet orally, once daily in the morning of Visit 1 (Week 0) for 28 or 52 weeks. The starting dose (30/8 milligram \[mg\] or 30/16 mg) was determined based on local practice and clinical judgment by the investigator. Based on the experience of symptomatic and asymptomatic hypotension, peripheral edema or significant tolerability, the doses were up-titrated to the highest target dose (60/32 mg).
|
|---|---|
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Number of Subjects With Treatment-emergent Adverse Events (TEAEs) of Special Interest up to Week 52/End of Study (EOS)
Oedema (mild)
|
131 Subjects
|
|
Number of Subjects With Treatment-emergent Adverse Events (TEAEs) of Special Interest up to Week 52/End of Study (EOS)
Oedema (moderate)
|
56 Subjects
|
|
Number of Subjects With Treatment-emergent Adverse Events (TEAEs) of Special Interest up to Week 52/End of Study (EOS)
Oedema(severe)
|
7 Subjects
|
|
Number of Subjects With Treatment-emergent Adverse Events (TEAEs) of Special Interest up to Week 52/End of Study (EOS)
Headache (mild)
|
31 Subjects
|
|
Number of Subjects With Treatment-emergent Adverse Events (TEAEs) of Special Interest up to Week 52/End of Study (EOS)
Headache (moderate)
|
17 Subjects
|
|
Number of Subjects With Treatment-emergent Adverse Events (TEAEs) of Special Interest up to Week 52/End of Study (EOS)
Flushing (mild)
|
3 Subjects
|
|
Number of Subjects With Treatment-emergent Adverse Events (TEAEs) of Special Interest up to Week 52/End of Study (EOS)
Symptomatic hypotension (mild)
|
4 Subjects
|
SECONDARY outcome
Timeframe: Baseline (Week 0) up to Week 52/EOSPopulation: SAF
Laboratory evaluations of blood and urine samples were performed, including hematology (hematocrit, hemoglobin, red blood cells count, white blood cells count, neutrophils, lymphocytes, monocytes, eosinophils, basophils, platelets), blood chemistry (sodium, potassium, chloride, bicarbonate, uric acid, total protein, albumin, calcium, blood urea nitrogen, creatinine, aspartate transaminase, alanine transaminase, lactate dehydrogenase, gamma glutamyl transferase, alkaline phosphatase, creatine kinase, total bilirubin, direct bilirubin, total cholesterol, low density lipoprotein cholesterol, high density lipoprotein cholesterol, triglycerides, fasting glucose), urinalysis (pH, blood, specific gravity, glucose, protein, cells/sediment). A laboratory test abnormality considered clinically relevant, for example, causing withdrawal by subject, requiring treatment or causing apparent clinical manifestations, or judged relevant by the investigator, were reported as AEs.
Outcome measures
| Measure |
Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106)
n=508 Participants
Subjects received nifedipine gastrointestinal therapeutic system (GITS) / candesartan cilexetil fixed dose combination (FDC) (BAY98-7106) tablet orally, once daily in the morning of Visit 1 (Week 0) for 28 or 52 weeks. The starting dose (30/8 milligram \[mg\] or 30/16 mg) was determined based on local practice and clinical judgment by the investigator. Based on the experience of symptomatic and asymptomatic hypotension, peripheral edema or significant tolerability, the doses were up-titrated to the highest target dose (60/32 mg).
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|---|---|
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Number of Subjects With Clinically Relevant Changes in Laboratory Parameters
|
0 Subjects
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Weeks 28 and 52Population: Modified intention-to-treat analysis set (mITT): All the subjects enrolled into the open-label treatment period and took at least one unit of the study medication.
Outcome measures
| Measure |
Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106)
n=508 Participants
Subjects received nifedipine gastrointestinal therapeutic system (GITS) / candesartan cilexetil fixed dose combination (FDC) (BAY98-7106) tablet orally, once daily in the morning of Visit 1 (Week 0) for 28 or 52 weeks. The starting dose (30/8 milligram \[mg\] or 30/16 mg) was determined based on local practice and clinical judgment by the investigator. Based on the experience of symptomatic and asymptomatic hypotension, peripheral edema or significant tolerability, the doses were up-titrated to the highest target dose (60/32 mg).
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|---|---|
|
Change From Baseline In Mean Seated Systolic Blood Pressure (MSSBP) At Weeks 28 And 52
Baseline
|
170.7 millimeter of mercury (mmHg)
Standard Deviation 8.9 • Interval 8.9 to
|
|
Change From Baseline In Mean Seated Systolic Blood Pressure (MSSBP) At Weeks 28 And 52
Change at Week 28
|
-30.4 millimeter of mercury (mmHg)
Standard Deviation 17.7 • Interval 17.7 to
|
|
Change From Baseline In Mean Seated Systolic Blood Pressure (MSSBP) At Weeks 28 And 52
Change at Week 52
|
-30.1 millimeter of mercury (mmHg)
Standard Deviation 18.4 • Interval 18.4 to
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Weeks 28 and 52Population: mITT
Outcome measures
| Measure |
Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106)
n=508 Participants
Subjects received nifedipine gastrointestinal therapeutic system (GITS) / candesartan cilexetil fixed dose combination (FDC) (BAY98-7106) tablet orally, once daily in the morning of Visit 1 (Week 0) for 28 or 52 weeks. The starting dose (30/8 milligram \[mg\] or 30/16 mg) was determined based on local practice and clinical judgment by the investigator. Based on the experience of symptomatic and asymptomatic hypotension, peripheral edema or significant tolerability, the doses were up-titrated to the highest target dose (60/32 mg).
|
|---|---|
|
Change From Baseline in Mean Seated Diastolic Blood Pressure (MSDBP) at Weeks 28 and 52
Baseline
|
95.6 millimeter of mercury (mmHg)
Standard Deviation 10.4 • Interval 10.4 to
|
|
Change From Baseline in Mean Seated Diastolic Blood Pressure (MSDBP) at Weeks 28 and 52
Change at Week 28
|
-12.7 millimeter of mercury (mmHg)
Standard Deviation 10.6 • Interval 10.6 to
|
|
Change From Baseline in Mean Seated Diastolic Blood Pressure (MSDBP) at Weeks 28 and 52
Change at Week 52
|
-12.8 millimeter of mercury (mmHg)
Standard Deviation 10.7 • Interval 10.7 to
|
SECONDARY outcome
Timeframe: Weeks 28 and 52Population: mITT
Control rate was defined as the percentage of subjects that reached a predetermined blood pressure (BP) target of BP less than (\<) 140/90 mmHg.
Outcome measures
| Measure |
Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106)
n=508 Participants
Subjects received nifedipine gastrointestinal therapeutic system (GITS) / candesartan cilexetil fixed dose combination (FDC) (BAY98-7106) tablet orally, once daily in the morning of Visit 1 (Week 0) for 28 or 52 weeks. The starting dose (30/8 milligram \[mg\] or 30/16 mg) was determined based on local practice and clinical judgment by the investigator. Based on the experience of symptomatic and asymptomatic hypotension, peripheral edema or significant tolerability, the doses were up-titrated to the highest target dose (60/32 mg).
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|---|---|
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Blood Pressure Control Rate at Weeks 28 and 52
Week 28
|
51.4 percentage of subjects
|
|
Blood Pressure Control Rate at Weeks 28 and 52
Week 52
|
51.6 percentage of subjects
|
SECONDARY outcome
Timeframe: Weeks 28 and 52Population: mITT
Response rate was defined as the percentage of subjects who achieved a systolic blood pressure response (MSSBP of \<140 mmHg or a reduction of MSSBP of more than (\>) 20 mmHg from baseline value), or a diastolic blood pressure response (MSDBP of \<90 mmHg or a reduction of MSDBP of \>10 mmHg from baseline value).
Outcome measures
| Measure |
Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106)
n=508 Participants
Subjects received nifedipine gastrointestinal therapeutic system (GITS) / candesartan cilexetil fixed dose combination (FDC) (BAY98-7106) tablet orally, once daily in the morning of Visit 1 (Week 0) for 28 or 52 weeks. The starting dose (30/8 milligram \[mg\] or 30/16 mg) was determined based on local practice and clinical judgment by the investigator. Based on the experience of symptomatic and asymptomatic hypotension, peripheral edema or significant tolerability, the doses were up-titrated to the highest target dose (60/32 mg).
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|---|---|
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Blood Pressure Response Rate at Weeks 28 and 52
Week 28
|
86.6 percentage of subjects
|
|
Blood Pressure Response Rate at Weeks 28 and 52
Week 52
|
86.2 percentage of subjects
|
Adverse Events
Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106)
Serious events: 15 serious events
Other events: 279 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106)
n=508 participants at risk
Subjects received nifedipine gastrointestinal therapeutic system (GITS) / candesartan cilexetil fixed dose combination (FDC) (BAY98-7106) tablet orally, once daily in the morning of Visit 1 (Week 0) for 28 or 52 weeks. The starting dose (30/8 milligram \[mg\] or 30/16 mg) was determined based on local practice and clinical judgment by the investigator. Based on the experience of symptomatic and asymptomatic hypotension, peripheral edema or significant tolerability, the doses were up-titrated to the highest target dose (60/32 mg).
|
|---|---|
|
Blood and lymphatic system disorders
Aplastic anaemia
|
0.20%
1/508 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected from the time of first study drug administration up to 7 days after Week 52/EOS
One death reported under SAE happened approximately 6 months after the subject had completed the study due to malignant melanoma of head and neck with metastasis to lung and liver, not related to the treatment.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.20%
1/508 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected from the time of first study drug administration up to 7 days after Week 52/EOS
One death reported under SAE happened approximately 6 months after the subject had completed the study due to malignant melanoma of head and neck with metastasis to lung and liver, not related to the treatment.
|
|
Cardiac disorders
Coronary artery disease
|
0.20%
1/508 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected from the time of first study drug administration up to 7 days after Week 52/EOS
One death reported under SAE happened approximately 6 months after the subject had completed the study due to malignant melanoma of head and neck with metastasis to lung and liver, not related to the treatment.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.20%
1/508 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected from the time of first study drug administration up to 7 days after Week 52/EOS
One death reported under SAE happened approximately 6 months after the subject had completed the study due to malignant melanoma of head and neck with metastasis to lung and liver, not related to the treatment.
|
|
Gastrointestinal disorders
Colitis
|
0.20%
1/508 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected from the time of first study drug administration up to 7 days after Week 52/EOS
One death reported under SAE happened approximately 6 months after the subject had completed the study due to malignant melanoma of head and neck with metastasis to lung and liver, not related to the treatment.
|
|
General disorders
Chest pain
|
0.20%
1/508 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected from the time of first study drug administration up to 7 days after Week 52/EOS
One death reported under SAE happened approximately 6 months after the subject had completed the study due to malignant melanoma of head and neck with metastasis to lung and liver, not related to the treatment.
|
|
General disorders
Pyrexia
|
0.20%
1/508 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected from the time of first study drug administration up to 7 days after Week 52/EOS
One death reported under SAE happened approximately 6 months after the subject had completed the study due to malignant melanoma of head and neck with metastasis to lung and liver, not related to the treatment.
|
|
Infections and infestations
Chronic sinusitis
|
0.20%
1/508 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected from the time of first study drug administration up to 7 days after Week 52/EOS
One death reported under SAE happened approximately 6 months after the subject had completed the study due to malignant melanoma of head and neck with metastasis to lung and liver, not related to the treatment.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.20%
1/508 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected from the time of first study drug administration up to 7 days after Week 52/EOS
One death reported under SAE happened approximately 6 months after the subject had completed the study due to malignant melanoma of head and neck with metastasis to lung and liver, not related to the treatment.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.20%
1/508 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs) were collected from the time of first study drug administration up to 7 days after Week 52/EOS
One death reported under SAE happened approximately 6 months after the subject had completed the study due to malignant melanoma of head and neck with metastasis to lung and liver, not related to the treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.20%
1/508 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected from the time of first study drug administration up to 7 days after Week 52/EOS
One death reported under SAE happened approximately 6 months after the subject had completed the study due to malignant melanoma of head and neck with metastasis to lung and liver, not related to the treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.20%
1/508 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected from the time of first study drug administration up to 7 days after Week 52/EOS
One death reported under SAE happened approximately 6 months after the subject had completed the study due to malignant melanoma of head and neck with metastasis to lung and liver, not related to the treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.20%
1/508 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected from the time of first study drug administration up to 7 days after Week 52/EOS
One death reported under SAE happened approximately 6 months after the subject had completed the study due to malignant melanoma of head and neck with metastasis to lung and liver, not related to the treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.20%
1/508 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected from the time of first study drug administration up to 7 days after Week 52/EOS
One death reported under SAE happened approximately 6 months after the subject had completed the study due to malignant melanoma of head and neck with metastasis to lung and liver, not related to the treatment.
|
|
Nervous system disorders
Syncope
|
0.20%
1/508 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were collected from the time of first study drug administration up to 7 days after Week 52/EOS
One death reported under SAE happened approximately 6 months after the subject had completed the study due to malignant melanoma of head and neck with metastasis to lung and liver, not related to the treatment.
|
Other adverse events
| Measure |
Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106)
n=508 participants at risk
Subjects received nifedipine gastrointestinal therapeutic system (GITS) / candesartan cilexetil fixed dose combination (FDC) (BAY98-7106) tablet orally, once daily in the morning of Visit 1 (Week 0) for 28 or 52 weeks. The starting dose (30/8 milligram \[mg\] or 30/16 mg) was determined based on local practice and clinical judgment by the investigator. Based on the experience of symptomatic and asymptomatic hypotension, peripheral edema or significant tolerability, the doses were up-titrated to the highest target dose (60/32 mg).
|
|---|---|
|
General disorders
Fatigue
|
3.5%
18/508 • Number of events 20 • Treatment Emergent Adverse Events (TEAEs) were collected from the time of first study drug administration up to 7 days after Week 52/EOS
One death reported under SAE happened approximately 6 months after the subject had completed the study due to malignant melanoma of head and neck with metastasis to lung and liver, not related to the treatment.
|
|
General disorders
Oedema
|
10.8%
55/508 • Number of events 80 • Treatment Emergent Adverse Events (TEAEs) were collected from the time of first study drug administration up to 7 days after Week 52/EOS
One death reported under SAE happened approximately 6 months after the subject had completed the study due to malignant melanoma of head and neck with metastasis to lung and liver, not related to the treatment.
|
|
General disorders
Oedema peripheral
|
29.5%
150/508 • Number of events 239 • Treatment Emergent Adverse Events (TEAEs) were collected from the time of first study drug administration up to 7 days after Week 52/EOS
One death reported under SAE happened approximately 6 months after the subject had completed the study due to malignant melanoma of head and neck with metastasis to lung and liver, not related to the treatment.
|
|
Infections and infestations
Nasopharyngitis
|
5.3%
27/508 • Number of events 30 • Treatment Emergent Adverse Events (TEAEs) were collected from the time of first study drug administration up to 7 days after Week 52/EOS
One death reported under SAE happened approximately 6 months after the subject had completed the study due to malignant melanoma of head and neck with metastasis to lung and liver, not related to the treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
4.9%
25/508 • Number of events 29 • Treatment Emergent Adverse Events (TEAEs) were collected from the time of first study drug administration up to 7 days after Week 52/EOS
One death reported under SAE happened approximately 6 months after the subject had completed the study due to malignant melanoma of head and neck with metastasis to lung and liver, not related to the treatment.
|
|
Nervous system disorders
Dizziness
|
9.3%
47/508 • Number of events 55 • Treatment Emergent Adverse Events (TEAEs) were collected from the time of first study drug administration up to 7 days after Week 52/EOS
One death reported under SAE happened approximately 6 months after the subject had completed the study due to malignant melanoma of head and neck with metastasis to lung and liver, not related to the treatment.
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Nervous system disorders
Headache
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9.3%
47/508 • Number of events 60 • Treatment Emergent Adverse Events (TEAEs) were collected from the time of first study drug administration up to 7 days after Week 52/EOS
One death reported under SAE happened approximately 6 months after the subject had completed the study due to malignant melanoma of head and neck with metastasis to lung and liver, not related to the treatment.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60