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Trial record 62 of 143 for:    NIFEDIPINE

Efficacy Study of Nifedipine Controlled-Release Tablets (Xin Ran) to Treat Early Morning Blood Pressure and Central Arterial Pressure

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ClinicalTrials.gov Identifier: NCT02357615
Recruitment Status : Unknown
Verified December 2014 by Shanghai Shyndec Pharmaceutical Co., Ltd..
Recruitment status was:  Recruiting
First Posted : February 6, 2015
Last Update Posted : February 6, 2015
Sponsor:
Information provided by (Responsible Party):
Shanghai Shyndec Pharmaceutical Co., Ltd.

Brief Summary:
The purpose of this study is to compare nifedipine controlled-release (CR) tablets (Xin Ran) with nifedipine controlled-release tablets (Adalat)in the treatment of Early Morning Blood Pressure and Central Arterial Pressure.

Condition or disease Intervention/treatment Phase
Essential Hypertension Drug: nifedipine CR tablets (Xin Ran) Drug: Adalat Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 244 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : December 2014
Estimated Primary Completion Date : June 2015
Estimated Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Nifedipine

Arm Intervention/treatment
Experimental: nifedipine CR tablets (Xin Ran)
Subjects will take a nifedipine controlled-release tablet (30 mg, Xin Ran) orally in every morning for a 8-week treatment period.
Drug: nifedipine CR tablets (Xin Ran)
Active Comparator: nifedipine CR tablets (Adalat)
Subjects will take a nifedipine controlled-release tablet (30 mg, Adalat) orally in every morning for a 8-week treatment period.
Drug: Adalat



Primary Outcome Measures :
  1. change in the average of early morning blood pressure mean systolic and diastolic pressure from baseline [ Time Frame: 8 weeks ]
    early morning blood pressure mean systolic and diastolic pressure measured by Omron-7080-IC calculated as the mean of all of the early morning blood pressure mean systolic and diastolic pressure measurements for 7 consecutive days after 8 weeks.


Secondary Outcome Measures :
  1. change in central systolic blood pressure from baseline . [ Time Frame: 8 weeks ]
  2. change in central diastolic blood pressure from baseline . [ Time Frame: 8 weeks ]
  3. change in central pulse pressure from baseline . [ Time Frame: 8 weeks ]
  4. change in augmentation index from baseline . [ Time Frame: 8 weeks ]
  5. change in mean systolic and diastolic pressure from baseline [ Time Frame: 8 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Voluntarily participate and must sign informed consent form
  • Mild to moderate essential hypertension (SBP 140-179 mmHg and/or DBP 90-109 mmHg)
  • The mean morning blood press of one week >135/85 mmHg

Exclusion Criteria:

  • Secondary hypertension and malignant hypertension
  • Pregnant or nursing women, or patients that cannot guarantee to take effective contraception measures
  • Baseline SBP≥180 mmHg or DBP≥110 mmHg, or patients with cerebral, cardiac or renal complications
  • Have following complications: cerebrovascular accident within 6 months, myocardial infarction or cardiac failure, macroaneurysm or dissecting aneurysm, definite angina, A-V block of grade 2 or higher, sick sinus syndrome, atrial fibrillation or other malignant arrhythmia
  • Clinical significant diseases of heart, lung, liver, kidney and hematologic system or malignant tumors, HIV infection, uncontrolled diabetes (fasting blood glucose ≥7.0 mmol/L, 2-hour postprandial blood glucose ≥7.8 mmol/L)
  • Kock pouch
  • Sever gastrointestinal stenosis
  • Abnormal laboratory values with clinical significance, including serum potassium <3.5 or >5.5 mmol/L, glutamic-pyruvic transaminase (ALT) or glutamic oxalacetic transaminase (AST) >2-fold upper limit of normal (ULN), Cr >ULN
  • Gastrointestinal abnormalities or surgery that may interfere with drug absorption
  • Hyperthyroidism or hypothyroidism
  • Allergic to any ingredient or metabolite of investigational drug or drugs of similar structure
  • Psychological diseases, acrasia, cannot express explicitly
  • Patients whose mood may be affected by variations in blood pressure, which in turn increases blood pressure
  • Anxiety disorders, depression or cannot follow study protocol
  • BMI >30
  • Night shift, irregular sleep patterns or insomnia
  • participate in other clinical trials within 3 months
  • other conditions that investigators consider unsuitable for participation

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): NCT02357615


Contacts
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Contact: Chongping Liu (86)21-62102186

Locations
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China
Ruijin Hospital Affiliated to Shanghai Jiao Tong University Medical School Recruiting
Shanghai, China
Contact: Pingjin Gao         
Sponsors and Collaborators
Shanghai Shyndec Pharmaceutical Co., Ltd.

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Responsible Party: Shanghai Shyndec Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT02357615     History of Changes
Other Study ID Numbers: CH-004PIV -2
First Posted: February 6, 2015    Key Record Dates
Last Update Posted: February 6, 2015
Last Verified: December 2014
Additional relevant MeSH terms:
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Nifedipine
Essential Hypertension
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