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Trial record 31 of 143 for:    NIFEDIPINE

Efficacy Study of Nifedipine Controlled-Release Tablets (Xin Ran) to Treat Mild to Moderate Essential Hypertension

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ClinicalTrials.gov Identifier: NCT02031861
Recruitment Status : Completed
First Posted : January 9, 2014
Last Update Posted : February 5, 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 mild to moderate essential hypertension.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Random, Open Label, Active Comparator-controlled Parallel Study to Evaluate the Efficacy of Nifedipine Controlled-released Tablets (Xin Ran) in Patients With Mild to Moderate Essential Hypertension
Study Start Date : February 2014
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

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 12-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 12-week treatment period.
Drug: nifedipine CR tablets (Adalat)



Primary Outcome Measures :
  1. change in morning blood pressure surge from baseline [ Time Frame: 12 weeks ]
  2. change in central systolic blood pressure, central diastolic blood pressure, central pulse pressure and augmentation index from baseline [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. change in morning blood pressure from baseline [ Time Frame: 12 weeks ]
  2. T/P ratio [ Time Frame: 12 weeks ]
  3. average reduction in systolic blood pressure from 18 to 24 hours after administration [ Time Frame: 12 weeks ]
  4. average reduction in diastolic blood pressure from 18 to 24 hours after administration [ Time Frame: 12 weeks ]
  5. smoothness index [ Time Frame: 12 weeks ]
  6. change in morning blood pressure surge from baseline [ Time Frame: 8 weeks ]
  7. change in central systolic blood pressure, central diastolic blood pressure, central pulse pressure and augmentation index from baseline [ Time Frame: 8 weeks ]
  8. change in morning blood pressure from baseline [ Time Frame: 8 weeks ]
  9. T/P ratio [ Time Frame: 8 weeks ]
  10. average reduction in systolic blood pressure from 18 to 24 hours after administration [ Time Frame: 8 weeks ]
  11. average reduction in diastolic blood pressure from 18 to 24 hours after administration [ Time Frame: 8 weeks ]
  12. smoothness index [ Time Frame: 8 weeks ]
  13. change in systolic blood pressure (SBP) from baseline [ Time Frame: 12 weeks ]
  14. change in diastolic blood pressure (DBP) from baseline [ Time Frame: 12 weeks ]

Other Outcome Measures:
  1. clinical laboratory test and adverse event [ Time Frame: 12 weeks ]


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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)
  • Average DBP measured by 24-hour ambulatory blood pressure monitoring (ABPM) ≥80 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
  • Uric acid >ULN with the diagnosis of gout
  • 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
  • Heavy smokers (>25 cigarettes every day), alcoholics (>250 ml liquor every day), drug addicts
  • 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): NCT02031861


Locations
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China, Shanghai
Ruijin Hospital Affiliated to Shanghai Jiao Tong University Medical School
Shanghai, Shanghai, China, 200025
Sponsors and Collaborators
Shanghai Shyndec Pharmaceutical Co., Ltd.
Investigators
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Principal Investigator: Pingjin Gao Ruijin Hospital Affiliated to Shanghai Jiao Tong University Medical School

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Responsible Party: Shanghai Shyndec Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT02031861     History of Changes
Other Study ID Numbers: CH-004PIV
First Posted: January 9, 2014    Key Record Dates
Last Update Posted: February 5, 2015
Last Verified: April 2014
Additional relevant MeSH terms:
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Nifedipine
Hypertension
Essential 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