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

Sponsor
Shanghai Shyndec Pharmaceutical Co., Ltd. (Industry)
Overall Status
Unknown status
CT.gov ID
NCT02357615
Collaborator
(none)
244
Enrollment
1
Location
2
Arms
9
Duration (Months)
27.1
Patients Per Site Per Month

Study Details

Study Description

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
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
244 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Study Start Date :
Dec 1, 2014
Anticipated Primary Completion Date :
Jun 1, 2015
Anticipated Study Completion Date :
Sep 1, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. change in the average of early morning blood pressure mean systolic and diastolic pressure from baseline [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 . [8 weeks]

  2. change in central diastolic blood pressure from baseline . [8 weeks]

  3. change in central pulse pressure from baseline . [8 weeks]

  4. change in augmentation index from baseline . [8 weeks]

  5. change in mean systolic and diastolic pressure from baseline [8 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ruijin Hospital Affiliated to Shanghai Jiao Tong University Medical School Shanghai China

Sponsors and Collaborators

  • Shanghai Shyndec Pharmaceutical Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Shanghai Shyndec Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT02357615
Other Study ID Numbers:
  • CH-004PIV -2
First Posted:
Feb 6, 2015
Last Update Posted:
Feb 6, 2015
Last Verified:
Dec 1, 2014
Additional relevant MeSH terms:
Essential Hypertension
Nifedipine

Study Results

No Results Posted as of Feb 6, 2015