Clinical trial NCT02413515: Blood Pressure Control of Nifedipine GITS 60mg Treatment in Chinese Hypertensive Subjects Uncontrolled on Starting-dose Mono-therapyo-therapy.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2015-04-10
Enrollment: 278
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Percentage of subjects with a Mean Sitting Systolic Blood Pressure (<130mmHg for subjects with diabetes and <140mmHg for others) of Nifedipine GITs 60mg
timeFrame: At week 8
Secondary outcomes:
measure: Changes in the Mean Sitting SBP(MSSBP) and Mean Sitting DBP(MSDBP) from baseline at Week 8
timeFrame: baseline and week 8
measure: 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
timeFrame: At week 2 and week 4
measure: The percentage of subjects with a MSDBP lower than 90 (80 for diabetis)
timeFrame: At week 2 and week 4
measure: The percentage of subjects achieving both a ≥10mmHg
timeFrame: At week 8
measure: Time to reach the MSSBP target (based on the BP measurements during office visits)
timeFrame: up to week 8
measure: 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
timeFrame: baseline and week 8
measure: incidence of all treatment-emergent adverse events
timeFrame: At week 8
measure: incidence of drug-related treatment-emergent adverse events
timeFrame: at week 8
Other outcomes:
Locations:
city: Fuzhou
country: China
state: Fujian
city: Tangshan
country: China
state: Hebei
city: Wudan
country: China
state: Hubei
city: Changsha
country: China
state: Hunan
city: Nanjing
country: China
state: Jiangsu
city: Xi'an
country: China
state: Shanxi
city: Hangzhou
country: China
state: Zhejiang
city: Beijing
country: China
city: Beijing
country: China
city: Beijing
country: China
city: Shandong
country: China
city: Shanghai
country: China
city: Tangshang
country: China
city: Tianjin
country: China
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: