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Completed

NCT Number: NCT02031861

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ruijin Hospital Affiliated to Shanghai Jiao Tong University Medical School

Shanghai, Shanghai Municipality, 200025, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

nifedipine CR tablets (Xin Ran)

Drug

nifedipine CR tablets (Adalat)

Drug

Primary outcomes

  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 outcomes

  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 outcomes

  1. clinical laboratory test and adverse event

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Shanghai Shyndec Pharmaceutical Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jan 9, 2014
Registry last updated
Feb 5, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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