Trial Condition(s):
Blood Pressure Control of Nifedipine GITS 60mg Treatment in Chinese Hypertensive Subjects Uncontrolled on Starting-dose Mono-therapyo-therapy. (ADEPT)
17677
Not Available
Not Available
To evaluate antihypertensive efficacy and tolerability of Nifedipine GITS 60mg treated for 8 weeks in Chinese hypertensive subjects who failed to achieve BP control with the starting-dose antihypertensive monotherapy.
-Subjects are eligible to be included in the study only if they meet all of the following criteria: - Aged 18 years or older, but less than 65 years; - Either male or female - BP is uncontrolled after at least 4 weeks of prior antihypertensive mono-therapy (the dosage of mono-therapy should be the starting dose of an angiotensin receptor blocker (ARB), angiotensin converting enzyme inhibitor (ACEI), b-blocker (BB), calcium channel blocker (CCB), or diuretic) both in the beginning and at the end of the screening period (uncontrolled BP is defined as MSSBP ≥140 and <160mmHg and/or MSDBP ≥ 90 and <100mmHg, and in the presence of diabetes mellitus: MSSBP ≥130 and <160mmHg and/or MSDBP ≥80 and <100mmHg);
- Subjects meeting any of the following criteria are to be excluded from the study: - Known hypersensitivity to nifedipine or to any of the following excipients, hypromellose, polyethylene oxide, magnesium stearate, sodium chloride, iron oxide red (E172/C.I.77491), cellulose acetate, polyethylene glycol 3350, hydroxypropyl cellulose, propylene glycol, titanium dioxide (E171/C.I.77891) - Evidence of secondary hypertension such as coarctation of the aorta, pheochromocytoma, hyperaldosteronism, etc. Severe gastro-intestinal tract narrowing; gastric banding; kock pouch (ileostomy after proctocolectomy) - Evidence of cardiovascular shock - Pregnant, possibly pregnant, planning to become pregnant or lactating women Received combination (two or more than two drugs combination) therapy or higher dosage (a higher dosage is defined as a higher dosage than the standard recommended starting dosage presented in the label of each drug) mono-therapy in the beginning or at the ending of the screening period. - History of cerebrovascular ischemic event (stroke or transient ischemic attack [TIA]) within 6 months - History of intracerebral hemorrhage or subarachnoid hemorrhage - History of hypertensive retinopathy - Any history of heart failure, New York Heart Association (NYHA) classification III or IV Severe coronary heart disease as manifested by a history of myocardial infarction or unstable angina in the past 12 months or a history of percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) - Clinically significant cardiac valvular disease - History of arrhythmia - Type 1 diabetes mellitus (DM) - Hyperkalemia history: a serum potassium level above the upper limit of normal in the laboratory range; - Liver disease or aspartate transaminase (AST) or alanine transaminase (ALT) levels >3 x upper limit of normal (ULN) - Renal insufficiency, defined as estimated glomerular filtration rate (eGFR) of <30 mL/min, or on hemodialysis
Locations | |
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Locations Investigative Site Beijing, China, 100037 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Shandong, China | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Tangshan, China, 063000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Beijing, China, 100028 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Tianjin, China, 300052 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Xi'an, China, 710061 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hangzhou, China, 310006 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Wudan, China, 430022 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Shanghai, China, 200025 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Changsha, China, 410008 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site fuzhou, China, 350001 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Beijing, China | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Tangshang, China | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Nanjing, China, 210008 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Tangshang, China | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Nanjing, China, 210008 | Contact Us: E-mail: [email protected] Phone: Not Available |
Blood Pressure Control of Nifedipine GITS 60mg Treatment in Chinese Hypertensive Subjects Uncontrolled on Starting-dose Mono-therapy: A prospective, open-label, multicenter, single-arm, 8-week study.
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
N/A
Blinding:
Open Label
Assignment:
Single Group Assignment
Trial Arms:
1