check_circleStudy Completed

Hypertension

Bayer Identifier:

17677

ClinicalTrials.gov Identifier:

NCT02413515

EudraCT Number:

Not Available

EU CT Number:

Not Available
Blood Pressure Control of Nifedipine GITS 60mg Treatment in Chinese Hypertensive Subjects Uncontrolled on Starting-dose Mono-therapyo-therapy.

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.

Key Participants Requirements

Sex

Both

Age

18 - 65 Years
  • -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);
  • - 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
March 2015 - August 2016
Phase
Phase 4
Could I Receive a placebo
No
Products
Adalat GITS (Nifedipine, BAYA1040)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Beijing, 100037, China
Completed
Shandong, China
Terminated
Tangshan, 063000, China
Completed
Beijing, 100028, China
Completed
Shandong, China
Completed
Tianjin, 300052, China
Completed
Xi'an, 710061, China
Completed
Hangzhou, 310006, China
Completed
Wudan, 430022, China
Completed
Shanghai, 200025, China
Completed
Changsha, 410008, China
Completed
fuzhou, 350001, China
Terminated
Beijing, China
Completed
Tangshang, China
Completed
Nanjing, 210008, China
Terminated
Tangshang, China
Terminated
Nanjing, 210008, China

Primary Outcome

  • Percentage of subjects with a Mean Sitting Systolic Blood Pressure (<130mmHg for subjects with diabetes and <140mmHg for others) of Nifedipine GITs 60mg
    date_rangeTime Frame:
    At week 8
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Changes in the Mean Sitting SBP(MSSBP) and Mean Sitting DBP(MSDBP) from baseline at Week 8
    date_rangeTime Frame:
    baseline and week 8
    enhanced_encryption
    Safety Issue:
    No
  • 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
    date_rangeTime Frame:
    At week 2 and week 4
    enhanced_encryption
    Safety Issue:
    No
  • The percentage of subjects with a MSDBP lower than 90 (80 for diabetis)
    date_rangeTime Frame:
    At week 2 and week 4
    enhanced_encryption
    Safety Issue:
    No
  • The percentage of subjects achieving both a ≥10mmHg
    date_rangeTime Frame:
    At week 8
    enhanced_encryption
    Safety Issue:
    No
  • 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
    date_rangeTime Frame:
    up to week 8
    enhanced_encryption
    Safety Issue:
    No
  • 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
    date_rangeTime Frame:
    baseline and week 8
    enhanced_encryption
    Safety Issue:
    No
  • incidence of all treatment-emergent adverse events
    date_rangeTime Frame:
    At week 8
    enhanced_encryption
    Safety Issue:
    Yes
  • incidence of drug-related treatment-emergent adverse events
    date_rangeTime Frame:
    at week 8
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

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.
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
N/A
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

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