Clinical Trials List
Protocol NumberBAY 98-7106/14728
2013-11-01 - 2014-11-30
Phase III
Terminated5
ICD-10I10
Essential (primary) hypertension
ICD-9401.9
Essential hypertension, unspecified
A Multicenter, Randomized, Double-Blind, Monotherapy-Controlled Study of Nifedipine Gastrointestinal Therapeutic System and Candesartan Cilexetil in Combination Taken Orally for 8 Weeks in Adult Subjects with Essential Hypertension who are Inadequately Controlled on Nifedipine Gastrointestinal Therapeutic System Monotherapy
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Trial Applicant
COVANCE TAIWAN SERVICES LIMITED
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Sponsor
Bayer Health Care AG
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- Shih-Hsien Sung Division of Cardiovascular Diseases
- 林幸榮 Division of Cardiovascular Diseases
- Kang-Ling Wang Division of Cardiovascular Diseases
- Wen-Chung Yu Division of Cardiovascular Diseases
- Tze-Fan Chao Division of Cardiovascular Diseases
- Tse-Min Lu Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- WEI-WEN LIN Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- Tsung-Hsien Lin Division of Cardiovascular Diseases
- Ye-Hsu Lu Division of Cardiovascular Diseases
- Cheng-An Chiu Division of Cardiovascular Diseases
- 溫文才 Division of Cardiovascular Diseases
- Chun-Yuan Chu Division of Cardiovascular Diseases
- 鄭凱鴻 Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 陳恬恩 Division of Cardiovascular Diseases
- Wen-Yuan Lin Division of Family Medicine
- Lien-Cheng Hsiao Division of Cardiovascular Diseases
- 陳業鵬 Division of Cardiovascular Diseases
- 楊晨佳 Division of Cardiovascular Diseases
- Chih Hsueh Lin Division of Family Medicine
- Po-Yen Ko Division of Cardiovascular Diseases
- 謝禮全 Division of Cardiovascular Diseases
- 吳宏彬 Division of Cardiovascular Diseases
- Shih-Sheng Chang Division of Cardiovascular Diseases
- 王宇澄 Division of Cardiovascular Diseases
- 張志斌 Division of Cardiovascular Diseases
- 盧炯睿 Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Condition/Disease
Treatment of essential hypertension inadequately controlled by monotherapy
Objectives
The primary objective is to demonstrate the superior efficacy of the fixed dose
combination (FDC) of nifedipine gastrointestinal therapeutic system (GITS)
and candesartan cilexetil compared to nifedipine GITS monotherapy in
subjects with essential hypertension not adequately controlled on nifedipine
GITS alone, based on the reduction of mean seated systolic blood pressure
(MSSBP).
The secondary objectives are:
To demonstrate the efficacy of the FDCs of nifedipine GITS and
candesartan cilexetil based on reduction of mean seated diastolic
blood pressure (MSDBP), response rate, control rate.
To demonstrate the efficacy of the FDCs of Nifedipine GITS and
candesartan cilexetil based on reduction of mean diastolic blood
pressure (DBP) and systolic blood pressure (SBP) on ambulatory
blood pressure monitoring (ABPM) over a 24-h period, during both
the daytime and night time
To explore the safety and tolerability of the FDC treatments.
Test Drug
BAY 98-7106( Nifedipine GITS / Candesartan cilexetil fixed dose combination)
Active Ingredient
BAY 98-7106( Nifedipine GITS / Candesartan cilexetil fixed dose combination)
Dosage Form
Coated Bilayer Core Tablet
Dosage
30/8 or 30/16
Endpoints
The primary objective is to demonstrate the superior efficacy of the FDC of nifedipine GITS and candesartan cilexetil compared to nifedipine GITS monotherapy in subjects with essential hypertension not adequately controlled on nifedipine GITS alone, based on reduction of MSSBP.
Inclution Criteria
Inclusion criteria
Specific inclusion criteria are detailed below.
1. Male and female subjects 18 years or older are eligible.
2. At Visit 0, subjects not treated with antihypertensive medications are to have MSSBP
≥ 160 mmHg and < 200 mmHg, and 24 hours MASBP≥ 130 mmHg ; those subjects
treated with antihypertensive medication are to have MSSBP ≥ 150 mmHg and
<200 mmHg, as measured by a calibrated electronic BP measuring device.
3. At Visit 3, subject must have MSSBP ≥ 140 mmHg before randomization.
4. Women of childbearing potential and men must agree to use adequate contraception
other than hormonal contraceptives when sexually active. This applies since signing
of the IC form until the last study drug administration.
5. Written informed consent.
Specific inclusion criteria are detailed below.
1. Male and female subjects 18 years or older are eligible.
2. At Visit 0, subjects not treated with antihypertensive medications are to have MSSBP
≥ 160 mmHg and < 200 mmHg, and 24 hours MASBP≥ 130 mmHg ; those subjects
treated with antihypertensive medication are to have MSSBP ≥ 150 mmHg and
<200 mmHg, as measured by a calibrated electronic BP measuring device.
3. At Visit 3, subject must have MSSBP ≥ 140 mmHg before randomization.
4. Women of childbearing potential and men must agree to use adequate contraception
other than hormonal contraceptives when sexually active. This applies since signing
of the IC form until the last study drug administration.
5. Written informed consent.
Exclusion Criteria
Exclusion criteria
1. MSSBP 200 mmHg and/or MSDBP 120 mmHg
2. MSDBP < 60 mmHg
3. If differences greater than 20 mmHg for SBP and 10 mmHg for DBP are present on 3
consecutive BP readings at Visit 0, the subject should be excluded from the study.
4. Any history of hypertensive emergency
5. Evidence of secondary hypertension such as coarctation of the aorta,
pheochromocytoma, hyperaldosteronism, etc.
6. Cerebrovascular ischemic event (stroke, transient ischemic attack [TIA]) within the
previous 12 months
7. History of intracerebral hemorrhage or subarachnoid hemorrhage
8. History of hypertensive retinopathy – known Keith-Wagener Grade III or IV
9. Any history of heart failure, New York Heart Association (NYHA) classification III or
IV
10. Severe coronary heart disease as manifest by a history of myocardial infarction or
unstable angina in the last 6 months prior to visit 0.
11. Clinically significant cardiac valvular disease
12. Subjects with an aortic aneurysm that, in the opinion of the investigator, will be
unsuitable to be enrolled in the study.
13. Type 1 diabetes mellitus (DM) or poorly controlled Type 2 DM as evidenced by
glycosylated hemoglobin (HbA1C) of greater than 9% on visit 0.
14. History of malignancy in the last 5 years, excluding treated basal or non-melanoma
skin cancer, or treated cervical carcinoma in situ
15. Hyperkalemia: potassium above the upper limit of normal in the laboratory range
16. Present severe rhythm or conduction disorder, eg.: Atrial fibrillation
Second or third degree heart block without a pacemaker.
17. Subjects who have night employment (night shift).
18. Surgical or medical conditions that might alter the metabolism, excretion or
distribution or absorption of any drug
o Gastrointestinal disease or surgery resulting in the potential for malabsorption
with the exception of lactose intolerance
o Severe gastro-intestinal tract narrowing; gastric banding; kock pouch (ileostomy
after proctocolectomy)
o Cholestasis or biliary obstruction or history of pancreatic injury or disease.
o Liver disease or aspartate transaminase (AST) or alanine transaminase (ALT)
levels >3 x upper limit of normal (ULN) at Screening Visit
o Renal insufficiency, defined as estimated glomerular filtration rate (estimated
glomerular filtration rate [GFR]) of < 30 mL/min (see Section 7.6.2), or on
hemodialysis
19. Investigational study participation with receipt of investigational study medication
within the last month
20. Previous assignment to treatment in this study
21. Allergies or known intolerance to one of the investigational drugs/drug class or to one
of their ingredients
22. Female subjects who are pregnant or lactating.
23. History of non-compliance, alcoholism, drug abuse or any other condition that in the
opinion of the investigator will compromise successful completion of the study.
24. Subjects with pre-planned surgery during the course of the study
25. Inability to stop any of the medications listed in the prohibited concomitant
medication list (see Section 6.9).
26. Subjects who are on treatment with any drug approved for the treatment of
hypertension, when prescribed for any reason other than control of blood pressure.
27. Close affiliation with the investigational site; eg. a close relative of the investigator,
dependent person (eg. employee or student of the investigational site)
1. MSSBP 200 mmHg and/or MSDBP 120 mmHg
2. MSDBP < 60 mmHg
3. If differences greater than 20 mmHg for SBP and 10 mmHg for DBP are present on 3
consecutive BP readings at Visit 0, the subject should be excluded from the study.
4. Any history of hypertensive emergency
5. Evidence of secondary hypertension such as coarctation of the aorta,
pheochromocytoma, hyperaldosteronism, etc.
6. Cerebrovascular ischemic event (stroke, transient ischemic attack [TIA]) within the
previous 12 months
7. History of intracerebral hemorrhage or subarachnoid hemorrhage
8. History of hypertensive retinopathy – known Keith-Wagener Grade III or IV
9. Any history of heart failure, New York Heart Association (NYHA) classification III or
IV
10. Severe coronary heart disease as manifest by a history of myocardial infarction or
unstable angina in the last 6 months prior to visit 0.
11. Clinically significant cardiac valvular disease
12. Subjects with an aortic aneurysm that, in the opinion of the investigator, will be
unsuitable to be enrolled in the study.
13. Type 1 diabetes mellitus (DM) or poorly controlled Type 2 DM as evidenced by
glycosylated hemoglobin (HbA1C) of greater than 9% on visit 0.
14. History of malignancy in the last 5 years, excluding treated basal or non-melanoma
skin cancer, or treated cervical carcinoma in situ
15. Hyperkalemia: potassium above the upper limit of normal in the laboratory range
16. Present severe rhythm or conduction disorder, eg.: Atrial fibrillation
Second or third degree heart block without a pacemaker.
17. Subjects who have night employment (night shift).
18. Surgical or medical conditions that might alter the metabolism, excretion or
distribution or absorption of any drug
o Gastrointestinal disease or surgery resulting in the potential for malabsorption
with the exception of lactose intolerance
o Severe gastro-intestinal tract narrowing; gastric banding; kock pouch (ileostomy
after proctocolectomy)
o Cholestasis or biliary obstruction or history of pancreatic injury or disease.
o Liver disease or aspartate transaminase (AST) or alanine transaminase (ALT)
levels >3 x upper limit of normal (ULN) at Screening Visit
o Renal insufficiency, defined as estimated glomerular filtration rate (estimated
glomerular filtration rate [GFR]) of < 30 mL/min (see Section 7.6.2), or on
hemodialysis
19. Investigational study participation with receipt of investigational study medication
within the last month
20. Previous assignment to treatment in this study
21. Allergies or known intolerance to one of the investigational drugs/drug class or to one
of their ingredients
22. Female subjects who are pregnant or lactating.
23. History of non-compliance, alcoholism, drug abuse or any other condition that in the
opinion of the investigator will compromise successful completion of the study.
24. Subjects with pre-planned surgery during the course of the study
25. Inability to stop any of the medications listed in the prohibited concomitant
medication list (see Section 6.9).
26. Subjects who are on treatment with any drug approved for the treatment of
hypertension, when prescribed for any reason other than control of blood pressure.
27. Close affiliation with the investigational site; eg. a close relative of the investigator,
dependent person (eg. employee or student of the investigational site)
The Estimated Number of Participants
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Taiwan
69 participants
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Global
684 participants
