Trial Condition(s):

Hypertension

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

Bayer Identifier:

17677

ClinicalTrials.gov Identifier:

NCT02413515

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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.

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

Trial Summary

Enrollment Goal
278
Trial Dates
black-arrow
Phase
4
Could I receive a placebo?
No
Products
Adalat GITS (Nifedipine, BAYA1040)
Accepts Healthy Volunteers
No

Where to Participate

Loading...
Locations
Status
LocationsStatus
Locations

Investigative Site

Beijing, China, 100037

Status
Completed
 
Locations

Investigative Site

Shandong, China

Status
Completed
 
Locations

Investigative Site

Tangshan, China, 063000

Status
Terminated
 
Locations

Investigative Site

Beijing, China, 100028

Status
Completed
 
Locations

Investigative Site

Tianjin, China, 300052

Status
Completed
 
Locations

Investigative Site

Xi'an, China, 710061

Status
Completed
 
Locations

Investigative Site

Hangzhou, China, 310006

Status
Completed
 
Locations

Investigative Site

Wudan, China, 430022

Status
Completed
 
Locations

Investigative Site

Shanghai, China, 200025

Status
Completed
 
Locations

Investigative Site

Changsha, China, 410008

Status
Completed
 
Locations

Investigative Site

fuzhou, China, 350001

Status
Completed
 
Locations

Investigative Site

Beijing, China

Status
Terminated
 
Locations

Investigative Site

Tangshang, China

Status
Completed
 
Locations

Investigative Site

Nanjing, China, 210008

Status
Completed
 
Locations

Investigative Site

Tangshang, China

Status
Terminated
 
Locations

Investigative Site

Nanjing, China, 210008

Status
Terminated
 

Trial Design