Blood Pressure Control of Nifedipine GITS 60mg Treatment in Chinese Hypertensive Subjects Uncontrolled on Starting-dose Mono-therapyo-therapy.

Launched by BAYER · Apr 9, 2015

Keywords

ClinConnect Summary

Study design: it's a A prospective, open-label, multicenter, single-arm study. After a one- to two-week screening period, subjects receive Nifedipine GITS 60mg for 8 weeks.

The primary objective is to evaluate the antihypertensive efficacy of 8-week Nifedipine GITS 60mg treatment in Chinese hypertensive subjects who failed to achieve BP control with the starting-dose antihypertensive mono-therapy.

The secondary objective is to evaluate the tolerability of Nifedipine GITS 60mg.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * 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);
• Exclusion Criteria:
• * 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