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

Bayer

Status and phase

Completed

Phase 4

Conditions

Hypertension

Treatments

Drug: Nifedipine (Adalat GITS, BAY1040)

Study type

Interventional

Funder types

Industry

Identifiers

NCT02413515

17677

Details and patient eligibility

About

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.

Full description

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.

Enrollment

278 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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