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Trial record 15 of 143 for:    NIFEDIPINE

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

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ClinicalTrials.gov Identifier: NCT02413515
Recruitment Status : Completed
First Posted : April 10, 2015
Last Update Posted : August 4, 2017
Sponsor:
Information provided by (Responsible Party):
Bayer

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.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Nifedipine (Adalat GITS, BAY1040) Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 278 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Actual Study Start Date : March 26, 2015
Actual Primary Completion Date : August 8, 2016
Actual Study Completion Date : August 8, 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Nifedipine

Arm Intervention/treatment
Experimental: Arm 1
Single arm study,the eligible subjects will receive Nifedipine GITS 60mg for 8 weeks
Drug: Nifedipine (Adalat GITS, BAY1040)
Nifedipine GITS 60 mg tablet, once daily, oral intake, for 8 weeks treatment




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Changes in the Mean Sitting SBP(MSSBP) and Mean Sitting DBP(MSDBP) from baseline at Week 8 [ Time Frame: baseline and week 8 ]
  2. 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 ]
  3. The percentage of subjects with a MSDBP lower than 90 (80 for diabetis) [ Time Frame: At week 2 and week 4 ]
  4. The percentage of subjects achieving both a ≥10mmHg [ Time Frame: At week 8 ]
  5. Time to reach the MSSBP target (based on the BP measurements during office visits) [ Time Frame: up to week 8 ]
    The MSSBP target means : 140 mmHg for others, 130 mmHg for diabetes

  6. 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 ]
  7. incidence of all treatment-emergent adverse events [ Time Frame: At week 8 ]
  8. incidence of drug-related treatment-emergent adverse events [ Time Frame: at week 8 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02413515


Locations
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China, Fujian
Fuzhou, Fujian, China, 350001
China, Hebei
Tangshan, Hebei, China, 063000
China, Hubei
Wudan, Hubei, China, 430022
China, Hunan
Changsha, Hunan, China, 410008
China, Jiangsu
Nanjing, Jiangsu, China, 210008
China, Shanxi
Xi'an, Shanxi, China, 710061
China, Zhejiang
Hangzhou, Zhejiang, China, 310006
China
Beijing, China, 100028
Beijing, China, 100037
Beijing, China
Shandong, China
Shanghai, China, 200025
Tangshang, China
Tianjin, China, 300052
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer

Additional Information:
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02413515     History of Changes
Other Study ID Numbers: 17677
First Posted: April 10, 2015    Key Record Dates
Last Update Posted: August 4, 2017
Last Verified: August 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Nifedipine
Hypertension
Vascular Diseases
Cardiovascular Diseases
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Tocolytic Agents
Reproductive Control Agents