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

NCT ID: NCT02413515

Last Updated: 2017-08-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 278 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-26
• Study Completion Date: 2016-08-08

Brief Summary

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.

Detailed 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.

Conditions

Hypertension

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1

Single arm study,the eligible subjects will receive Nifedipine GITS 60mg for 8 weeks

Group Type: EXPERIMENTAL

Nifedipine (Adalat GITS, BAY1040)

Intervention Type: DRUG

Nifedipine GITS 60 mg tablet, once daily, oral intake, for 8 weeks treatment

Interventions

Nifedipine (Adalat GITS, BAY1040)

Nifedipine GITS 60 mg tablet, once daily, oral intake, for 8 weeks treatment

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Fuzhou, Fujian, China

Tangshan, Hebei, China

Wudan, Hubei, China

Changsha, Hunan, China

Nanjing, Jiangsu, China

Xi’an, Shanxi, China

Hangzhou, Zhejiang, China

Beijing, , China

Beijing, , China

Beijing, , China

Shandong, , China

Shanghai, , China

Tangshang, , China

Tianjin, , China

Countries

China

Other Identifiers

17677

Identifier Type: -

Identifier Source: org_study_id