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

Phase 4

Completed

• Conditions: Hypertension
• Interventions: Drug: Nifedipine (Adalat GITS, BAY1040)

• Registration Number: NCT02413515
• Lead Sponsor: Bayer

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.

Study Timeline

• Study Start: 2015-03-26
• Study First Submitted: 2015-04-02
• Study First Submitted QC: 2015-04-09
• Study First Posted: 2015-04-10
• Primary Completion: 2016-08-08
• Study Completion: 2016-08-08
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-03
• Last Update Posted: 2017-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 278

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);

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	Nifedipine (Adalat GITS, BAY1040)	Single arm study,the eligible subjects will receive Nifedipine GITS 60mg for 8 weeks

Primary Outcome Measures

Name	Time	Method
Percentage of subjects with a Mean Sitting Systolic Blood Pressure (<130mmHg for subjects with diabetes and <140mmHg for others) of Nifedipine GITs 60mg	At week 8

Secondary Outcome Measures

Name	Time	Method
Percentage of subjects with a Mean Sitting Systolic Blood Pressure Lower than 140mmHg and MSDBP less than 90 mmHg (130 and 80 for diabetis patients) of Nifedipine GITs 60mg	At week 2 and week 4
The percentage of subjects with a MSDBP lower than 90 (80 for diabetis)	At week 2 and week 4
The percentage of subjects achieving both a ≥10mmHg	At week 8
Changes in the Mean Sitting SBP(MSSBP) and Mean Sitting DBP(MSDBP) from baseline at Week 8	baseline and week 8
Time to reach the MSSBP target (based on the BP measurements during office visits)	up to week 8	The MSSBP target means : 140 mmHg for others, 130 mmHg for diabetes
Changes in the 24-h, daytime (from 06:00 to 22:00), and nighttime (from 22:00 to 06:00) average SBP and DBP assessed by ABPM from baseline at Week 8	baseline and week 8
incidence of drug-related treatment-emergent adverse events	at week 8
incidence of all treatment-emergent adverse events	At week 8