Hypertension
Conditions
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.
Interventions
DRUGNifedipine (Adalat GITS, BAY1040)
Nifedipine GITS 60 mg tablet, once daily, oral intake, for 8 weeks treatment
Sponsors
Bayer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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 | — |
| 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 |
Countries
China
Outcome results
None listed