Study 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

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

March 2015 - August 2016

Phase

Phase 4

Could I Receive a placebo

Products

Adalat GITS (Nifedipine, BAYA1040)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
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
Time Frame:
At week 8
Safety Issue:
No

Secondary Outcome

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

Additional Information

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