Back to resultsOpen-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
Primary Purpose
Hypertension
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106)
Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106)
Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106)
Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106)
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension focused on measuring Drug combination, Nifedipine GITS, Candesartan Cilexetil, Hypertension, Combination therapy
Eligibility Criteria
Inclusion Criteria:
- Subjects must have moderate to severe essential hypertension (Grade 2 or Grade 3, WHO classifications). At Visit 1, subjects not treated with antihypertensive medications are to have MSSBP of >/= 160 mmHg and < 200 mmHg, as measured by a calibrated electronic BP measuring device. For other subjects who are treated with antihypertensive medication before, they should have MSSBP >/= 160 mmHg and <200 mmHg after wash out.
- Women of childbearing potential and men must agree to use adequate contraception other than hormonal contraceptives when sexually active
Exclusion Criteria:
- Mean seated systolic blood pressure >/= 200 mmHg and/or mean seated diastolic blood pressure >/= 120 mm/Hg
- Mean seated diastolic blood pressure < 60 mm/Hg
- Differences greater than 20 mmHg for systolic blood pressure and 10 mmHg for diastolic blood pressure are present on 3 consecutive blood pressure readings at visit 0
- Any history of hypertensive emergency
- Evidence of secondary hypertension such as coarctation of the aorta, pheochromocytoma, hyperaldosteronism, etc.
- Cerebrovascular ischemic event (stroke, transient ischemic attack [TIA])within the previous 12 months
- History of intracerebral hemorrhage or subarachnoid hemorrhage
- History of hypertensive retinopathy - known Keith-Wagener Grade III or IV
- Any history of heart failure, New York Heart Association (NYHA) classification III or IV
- Severe coronary heart disease as manifest by a history of myocardial infarction or unstable angina in the last 6 months prior to visit 0
- Type 1 diabetes mellitus (DM) or poorly controlled Type 2 DM as evidenced by HbA1C of greater than 9% on visit 0.
- Hyperkalemia: potassium above the upper limit of normal in the laboratory range
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106)
Arm Description
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).
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
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.
Change From Baseline In Mean Seated Systolic Blood Pressure (MSSBP) At Weeks 28 And 52
Change From Baseline in Mean Seated Diastolic Blood Pressure (MSDBP) at 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.
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01788358
Brief Title
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
Official Title
Multicenter, Open-Label, Long-Term Safety and Efficacy Study of the Fixed Dose Combination of Nifedipine Gastrointestinal Therapeutic System and Candesartan Cilexetil in Adult Subjects With Moderate to Severe Essential Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
February 14, 2013 (Actual)
Primary Completion Date
May 1, 2014 (Actual)
Study Completion Date
May 1, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
Drug combination, Nifedipine GITS, Candesartan Cilexetil, Hypertension, Combination therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
508 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106)
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106)
Intervention Description
Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106), tablet, 30/8 mg, orally once daily
Intervention Type
Drug
Intervention Name(s)
Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106)
Intervention Description
Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106), tablet, 30/16 mg, orally once daily
Intervention Type
Drug
Intervention Name(s)
Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106)
Intervention Description
Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106), tablet, 60/16 mg, orally once daily
Intervention Type
Drug
Intervention Name(s)
Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106)
Intervention Description
Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106), tablet, 60/32 mg, orally once daily
Primary Outcome Measure Information:
Title
Number of Subjects With All Treatment-emergent Adverse Events (TEAEs) and Drug-related TEAEs up to Week 28
Description
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.
Time Frame
From the time of first study drug administration up to Week 28
Title
Number of Subjects With Treatment-emergent Adverse Events (TEAEs) of Special Interest up to Week 28
Description
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.
Time Frame
From the time of first study drug administration up to Week 28
Title
Number of Subjects With All Treatment-emergent Adverse Events (TEAEs) and Drug-related TEAEs up to Week 52/End of Study (EOS)
Description
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.
Time Frame
From the time of first study drug administration up to Week 52/EOS
Title
Number of Subjects With Treatment-emergent Adverse Events (TEAEs) of Special Interest up to Week 52/End of Study (EOS)
Description
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.
Time Frame
From the time of study treatment up to Week 52/EOS
Secondary Outcome Measure Information:
Title
Number of Subjects With Clinically Relevant Changes in Laboratory Parameters
Description
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.
Time Frame
Baseline (Week 0) up to Week 52/EOS
Title
Change From Baseline In Mean Seated Systolic Blood Pressure (MSSBP) At Weeks 28 And 52
Time Frame
Baseline (Week 0), Weeks 28 and 52
Title
Change From Baseline in Mean Seated Diastolic Blood Pressure (MSDBP) at Weeks 28 and 52
Time Frame
Baseline (Week 0), Weeks 28 and 52
Title
Blood Pressure Control Rate at Weeks 28 and 52
Description
Control rate was defined as the percentage of subjects that reached a predetermined blood pressure (BP) target of BP less than (<) 140/90 mmHg.
Time Frame
Weeks 28 and 52
Title
Blood Pressure Response Rate at Weeks 28 and 52
Description
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).
Time Frame
Weeks 28 and 52
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects must have moderate to severe essential hypertension (Grade 2 or Grade 3, WHO classifications). At Visit 1, subjects not treated with antihypertensive medications are to have MSSBP of >/= 160 mmHg and < 200 mmHg, as measured by a calibrated electronic BP measuring device. For other subjects who are treated with antihypertensive medication before, they should have MSSBP >/= 160 mmHg and <200 mmHg after wash out.
Women of childbearing potential and men must agree to use adequate contraception other than hormonal contraceptives when sexually active
Exclusion Criteria:
Mean seated systolic blood pressure >/= 200 mmHg and/or mean seated diastolic blood pressure >/= 120 mm/Hg
Mean seated diastolic blood pressure < 60 mm/Hg
Differences greater than 20 mmHg for systolic blood pressure and 10 mmHg for diastolic blood pressure are present on 3 consecutive blood pressure readings at visit 0
Any history of hypertensive emergency
Evidence of secondary hypertension such as coarctation of the aorta, pheochromocytoma, hyperaldosteronism, etc.
Cerebrovascular ischemic event (stroke, transient ischemic attack [TIA])within the previous 12 months
History of intracerebral hemorrhage or subarachnoid hemorrhage
History of hypertensive retinopathy - known Keith-Wagener Grade III or IV
Any history of heart failure, New York Heart Association (NYHA) classification III or IV
Severe coronary heart disease as manifest by a history of myocardial infarction or unstable angina in the last 6 months prior to visit 0
Type 1 diabetes mellitus (DM) or poorly controlled Type 2 DM as evidenced by HbA1C of greater than 9% on visit 0.
Hyperkalemia: potassium above the upper limit of normal in the laboratory range
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Foley
State/Province
Alabama
ZIP/Postal Code
36535
Country
United States
City
Carmichael
State/Province
California
ZIP/Postal Code
95608
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
City
Spring Valley
State/Province
California
ZIP/Postal Code
91978
Country
United States
City
Milford
State/Province
Connecticut
ZIP/Postal Code
06460
Country
United States
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33114-4192
Country
United States
City
Hallandale Beach
State/Province
Florida
ZIP/Postal Code
33009
Country
United States
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33083
Country
United States
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30338
Country
United States
City
Valparaiso
State/Province
Indiana
ZIP/Postal Code
46383
Country
United States
City
Newton
State/Province
Kansas
ZIP/Postal Code
67114
Country
United States
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67205
Country
United States
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40504
Country
United States
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70119
Country
United States
City
Auburn
State/Province
Maine
ZIP/Postal Code
04240
Country
United States
City
Elkridge
State/Province
Maryland
ZIP/Postal Code
21075
Country
United States
City
Brockton
State/Province
Massachusetts
ZIP/Postal Code
02301
Country
United States
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
City
Shelby
State/Province
North Carolina
ZIP/Postal Code
28150
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45224
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45245
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45246
Country
United States
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57702
Country
United States
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
City
New Tazewell
State/Province
Tennessee
ZIP/Postal Code
37825
Country
United States
City
Beaumont
State/Province
Texas
ZIP/Postal Code
77701
Country
United States
City
Bryan
State/Province
Texas
ZIP/Postal Code
77802
Country
United States
City
Carrollton
State/Province
Texas
ZIP/Postal Code
75010
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84109
Country
United States
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84121
Country
United States
City
Kenosha
State/Province
Wisconsin
ZIP/Postal Code
53142
Country
United States
City
Moorsel
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9310
Country
Belgium
City
Wetteren
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9230
Country
Belgium
City
Steenokkerzeel
State/Province
Vlaams Brabant
ZIP/Postal Code
1820
Country
Belgium
City
Deurne
ZIP/Postal Code
2100
Country
Belgium
City
HAM
ZIP/Postal Code
3545
Country
Belgium
City
Burnaby
State/Province
British Columbia
ZIP/Postal Code
V5G 1T4
Country
Canada
City
Langley
State/Province
British Columbia
ZIP/Postal Code
V3A 4H9
Country
Canada
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1K3
Country
Canada
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6T 0G1
Country
Canada
City
Burlington
State/Province
Ontario
ZIP/Postal Code
L7M 4Y1
Country
Canada
City
Etobicoke
State/Province
Ontario
ZIP/Postal Code
M8V 3X8
Country
Canada
City
London
State/Province
Ontario
ZIP/Postal Code
N5W 6A2
Country
Canada
City
Newmarket
State/Province
Ontario
ZIP/Postal Code
L3Y 5G8
Country
Canada
City
Sarnia
State/Province
Ontario
ZIP/Postal Code
N7T 4X3
Country
Canada
City
Stayner
State/Province
Ontario
ZIP/Postal Code
L0M 1S0
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4S 1Y2
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M9V 4B4
Country
Canada
City
Woodstock
State/Province
Ontario
ZIP/Postal Code
N4S 4G3
Country
Canada
City
Pointe-Claire
State/Province
Quebec
ZIP/Postal Code
H9R 3J1
Country
Canada
City
Ste-Foy
State/Province
Quebec
ZIP/Postal Code
G1W 1S2
Country
Canada
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
60313
Country
Germany
City
Bochum
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
44787
Country
Germany
City
Magdeburg
State/Province
Sachsen-Anhalt
ZIP/Postal Code
39104
Country
Germany
City
Görlitz
State/Province
Sachsen
ZIP/Postal Code
02826
Country
Germany
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04103
Country
Germany
City
Berlin
ZIP/Postal Code
12627
Country
Germany
City
Dresden
Country
Germany
City
Gdynia
ZIP/Postal Code
81-384
Country
Poland
City
Katowice
ZIP/Postal Code
40-040
Country
Poland
City
Warszawa
ZIP/Postal Code
01-192
Country
Poland
City
Wroclaw
ZIP/Postal Code
50-088
Country
Poland
City
Reading
State/Province
Berkshire
ZIP/Postal Code
RG2 0TG
Country
United Kingdom
City
Chesterfield
State/Province
Derbyshire
ZIP/Postal Code
S40 4AA
Country
United Kingdom
City
Blackpool
State/Province
Lancashire
ZIP/Postal Code
FY3 7EN
Country
United Kingdom
City
Bath
State/Province
Somerset
ZIP/Postal Code
BA3 2UH
Country
United Kingdom
City
Bury St Edmonds
State/Province
Suffolk
ZIP/Postal Code
IP30 9QU
Country
United Kingdom
City
Coventry
State/Province
Warwickshire
ZIP/Postal Code
CV6 4DD
Country
United Kingdom
City
Birmingham
State/Province
West Midlands
ZIP/Postal Code
B15 2SQ
Country
United Kingdom
City
Cardiff
ZIP/Postal Code
CF14 5GJ
Country
United Kingdom
City
Chorley
ZIP/Postal Code
PR7 7NA
Country
United Kingdom
City
Glasgow
ZIP/Postal Code
G20 OSP
Country
United Kingdom
City
Liverpool
ZIP/Postal Code
L22 0LG
Country
United Kingdom
City
Manchester
ZIP/Postal Code
M15 6SX
Country
United Kingdom
12. IPD Sharing Statement
Links:
URL
http://www.clinicaltrialsregister.eu/
Description
Click here to find information about studies related to Bayer Healthcare products conducted in Europe
Learn more about this trial
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
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