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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-004515-32 | EudraCT Number |
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This study examines the long term safety and efficacy of the Fixed Dose combination BAY98-7106 (nifedipine plus candesartan primarily at the highest dose in development) in patients with moderate to severe hypertension.
Patients meeting the entry criteria, will receive the Fixed Dose combination for 28 weeks, including 8 weeks with stepwise dose increase up to the high target dose. The first 200 subjects completing 28 weeks will continue treatment for additional 24 weeks (52 weeks in total).
Subjects who do not tolerate an increased dose will be treated at their highest tolerable dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106) | Experimental | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106) | Drug | Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106), tablet, 30/8 mg, orally once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With All Treatment-emergent Adverse Events (TEAEs) and Drug-related TEAEs up to Week 28 | 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. | From the time of first study drug administration up to Week 28 |
| Number of Subjects With Treatment-emergent Adverse Events (TEAEs) of Special Interest up to Week 28 | 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. | From the time of first study drug administration up to Week 28 |
| Number of Subjects With All Treatment-emergent Adverse Events (TEAEs) and Drug-related TEAEs up to Week 52/End of Study (EOS) | 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. | From the time of first study drug administration up to Week 52/EOS |
| Number of Subjects With Treatment-emergent Adverse Events (TEAEs) of Special Interest up to Week 52/End of Study (EOS) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Clinically Relevant Changes in Laboratory Parameters | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Foley | Alabama | 36535 | United States | |||
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| Label | URL |
|---|---|
| Click here to find information about studies related to Bayer Healthcare products conducted in Europe | View source |
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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.
The study was conducted at 70 study centers between 14 February 2013 (first subject first visit) and 1 May 2014 (last subject last visit).
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106) | Drug | Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106), tablet, 30/16 mg, orally once daily |
|
| Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106) | Drug | Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106), tablet, 60/16 mg, orally once daily |
|
| Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106) | Drug | Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106), tablet, 60/32 mg, orally once daily |
|
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. |
| From the time of study treatment up to Week 52/EOS |
| Baseline (Week 0) up to Week 52/EOS |
| Change From Baseline In Mean Seated Systolic Blood Pressure (MSSBP) At Weeks 28 And 52 | Baseline (Week 0), Weeks 28 and 52 |
| Change From Baseline in Mean Seated Diastolic Blood Pressure (MSDBP) at Weeks 28 and 52 | Baseline (Week 0), Weeks 28 and 52 |
| Blood Pressure Control Rate at Weeks 28 and 52 | Control rate was defined as the percentage of subjects that reached a predetermined blood pressure (BP) target of BP less than (<) 140/90 mmHg. | Weeks 28 and 52 |
| Blood Pressure Response Rate at Weeks 28 and 52 | 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). | Weeks 28 and 52 |
| Carmichael |
| California |
| 95608 |
| United States |
| Los Angeles | California | 90057 | United States |
| Spring Valley | California | 91978 | United States |
| Milford | Connecticut | 06460 | United States |
| Coral Gables | Florida | 33114-4192 | United States |
| Hallandale | Florida | 33009 | United States |
| Hollywood | Florida | 33083 | United States |
| Jacksonville | Florida | 32216 | United States |
| Jupiter | Florida | 33458 | United States |
| Tampa | Florida | 33606 | United States |
| Atlanta | Georgia | 30338 | United States |
| Valparaiso | Indiana | 46383 | United States |
| Newton | Kansas | 67114 | United States |
| Wichita | Kansas | 67205 | United States |
| Lexington | Kentucky | 40504 | United States |
| New Orleans | Louisiana | 70119 | United States |
| Auburn | Maine | 04240 | United States |
| Elkridge | Maryland | 21075 | United States |
| Brockton | Massachusetts | 02301 | United States |
| St Louis | Missouri | 63141 | United States |
| Shelby | North Carolina | 28150 | United States |
| Cincinnati | Ohio | 45224 | United States |
| Cincinnati | Ohio | 45245 | United States |
| Cincinnati | Ohio | 45246 | United States |
| Columbus | Ohio | 43213 | United States |
| Greenville | South Carolina | 29615 | United States |
| Mt. Pleasant | South Carolina | 29464 | United States |
| Rapid City | South Dakota | 57702 | United States |
| Nashville | Tennessee | 37203 | United States |
| New Tazewell | Tennessee | 37825 | United States |
| Beaumont | Texas | 77701 | United States |
| Bryan | Texas | 77802 | United States |
| Carrollton | Texas | 75010 | United States |
| Dallas | Texas | 75230 | United States |
| San Antonio | Texas | 78229 | United States |
| Salt Lake City | Utah | 84109 | United States |
| Salt Lake City | Utah | 84121 | United States |
| Kenosha | Wisconsin | 53142 | United States |
| Moorsel | Oost-Vlaanderen | 9310 | Belgium |
| Wetteren | Oost-Vlaanderen | 9230 | Belgium |
| Steenokkerzeel | Vlaams Brabant | 1820 | Belgium |
| Deurne | 2100 | Belgium |
| Ham | 3545 | Belgium |
| Burnaby | British Columbia | V5G 1T4 | Canada |
| Langley | British Columbia | V3A 4H9 | Canada |
| Vancouver | British Columbia | V5Z 1K3 | Canada |
| Brampton | Ontario | L6T 0G1 | Canada |
| Burlington | Ontario | L7M 4Y1 | Canada |
| Etobicoke | Ontario | M8V 3X8 | Canada |
| London | Ontario | N5W 6A2 | Canada |
| Newmarket | Ontario | L3Y 5G8 | Canada |
| Sarnia | Ontario | N7T 4X3 | Canada |
| Stayner | Ontario | L0M 1S0 | Canada |
| Toronto | Ontario | M4S 1Y2 | Canada |
| Toronto | Ontario | M9V 4B4 | Canada |
| Woodstock | Ontario | N4S 4G3 | Canada |
| Pointe-Claire | Quebec | H9R 3J1 | Canada |
| Ste-Foy | Quebec | G1W 1S2 | Canada |
| Frankfurt am Main | Hesse | 60313 | Germany |
| Bochum | North Rhine-Westphalia | 44787 | Germany |
| Görlitz | Saxony | 02826 | Germany |
| Leipzig | Saxony | 04103 | Germany |
| Magdeburg | Saxony-Anhalt | 39104 | Germany |
| Berlin | 12627 | Germany |
| Dresden | Germany |
| Gdynia | 81-384 | Poland |
| Katowice | 40-040 | Poland |
| Warsaw | 01-192 | Poland |
| Wroclaw | 50-088 | Poland |
| Reading | Berkshire | RG2 0TG | United Kingdom |
| Chesterfield | Derbyshire | S40 4AA | United Kingdom |
| Blackpool | Lancashire | FY3 7EN | United Kingdom |
| Bath | Somerset | BA3 2UH | United Kingdom |
| Bury Saint Edmonds | Suffolk | IP30 9QU | United Kingdom |
| Coventry | Warwickshire | CV6 4DD | United Kingdom |
| Birmingham | West Midlands | B15 2SQ | United Kingdom |
| Cardiff | CF14 5GJ | United Kingdom |
| Chorley | PR7 7NA | United Kingdom |
| Glasgow | G20 OSP | United Kingdom |
| Liverpool | L22 0LG | United Kingdom |
| Manchester | M15 6SX | United Kingdom |
| Treated |
|
| Completed Week 28 |
|
| Entered Extension to Week 52 |
|
| Completed Week 52 |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Systolic blood pressure | Mean | Standard Deviation | millimeter of mercury (mmHg) |
| |||||||||||||||||
| Diastolic blood pressure | Mean | Standard Deviation | mmHg |
|
| 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 | Number of Subjects With All Treatment-emergent Adverse Events (TEAEs) and Drug-related TEAEs up to Week 28 | 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. | Safety Analysis Set (SAF): All the subjects enrolled into the open-label treatment period and took at least one unit of the study medication. | Posted | Number | Subjects | From the time of first study drug administration up to Week 28 |
|
|
| |||||||||||||||||||||||||||||||||
| Primary | Number of Subjects With Treatment-emergent Adverse Events (TEAEs) of Special Interest up to Week 28 | 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. | SAF | Posted | Number | Subjects | From the time of first study drug administration up to Week 28 |
| |||||||||||||||||||||||||||||||||||
| Primary | Number of Subjects With All Treatment-emergent Adverse Events (TEAEs) and Drug-related TEAEs up to Week 52/End of Study (EOS) | 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. | SAF | Posted | Number | Subjects | From the time of first study drug administration up to Week 52/EOS |
|
| ||||||||||||||||||||||||||||||||||
| Primary | Number of Subjects With Treatment-emergent Adverse Events (TEAEs) of Special Interest up to Week 52/End of Study (EOS) | 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. | SAF | Posted | Number | Subjects | From the time of study treatment up to Week 52/EOS |
| |||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Clinically Relevant Changes in Laboratory Parameters | 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. | SAF | Posted | Number | Subjects | Baseline (Week 0) up to Week 52/EOS |
| |||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline In Mean Seated Systolic Blood Pressure (MSSBP) At Weeks 28 And 52 | 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. | Posted | Mean | Standard Deviation | millimeter of mercury (mmHg) | Baseline (Week 0), Weeks 28 and 52 |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Mean Seated Diastolic Blood Pressure (MSDBP) at Weeks 28 and 52 | mITT | Posted | Mean | Standard Deviation | millimeter of mercury (mmHg) | Baseline (Week 0), Weeks 28 and 52 |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Blood Pressure Control Rate at Weeks 28 and 52 | Control rate was defined as the percentage of subjects that reached a predetermined blood pressure (BP) target of BP less than (<) 140/90 mmHg. | mITT | Posted | Number | percentage of subjects | Weeks 28 and 52 |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Blood Pressure Response Rate at Weeks 28 and 52 | 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). | mITT | Posted | Number | percentage of subjects | Weeks 28 and 52 |
|
|
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). | 15 | 508 | 279 | 508 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Aplastic anaemia | Blood and lymphatic system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Chronic sinusitis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | Bayer HealthCare AG | clinical-trials-contact@bayerhealthcare.com |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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