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

Study Overview
=================
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.

Official Title
-----------------
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.

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: Nifedipine (Adalat GITS, BAY1040)


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>Single arm study,the eligible subjects will receive Nifedipine GITS 60mg for 8 weeks | Drug: Nifedipine (Adalat GITS, BAY1040)<br>* Nifedipine GITS 60 mg tablet, once daily, oral intake, for 8 weeks treatment<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the Mean Sitting SBP(MSSBP) and Mean Sitting DBP(MSDBP) from baseline at Week 8 |  | baseline and week 8 | 
| 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 | 
| Time to reach the MSSBP target (based on the BP measurements during office visits) | The MSSBP target means : 140 mmHg for others, 130 mmHg for diabetes | up to week 8 | 
| 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 all treatment-emergent adverse events |  | At week 8 | 
| incidence of drug-related treatment-emergent adverse events |  | at week 8 |