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Effect of Nifedipine GITS in Patients With Mild-to-moderate Primary Hypertension

Primary Purpose

Hypertension

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Nifedipine GITS
Sponsored by
Peking University First Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • a seated systolic BP (SBP) ≥140 mmHg and <180 mmHg and/or a seated diastolic BP (DBP) ≥90 mmHg and <110 mmHg;
  • an age ≥18 and ≤75 years;
  • those who had not taken any BP-lowering medications in 1 month before the study.

Exclusion Criteria:

  • a seated systolic BP (SBP) ≥180 mmHg and/or a seated diastolic BP ≥110 mmHg;
  • secondary hypertension;
  • diagnosed heart failure or stroke;
  • Any of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) was above 1.5 times of it's normal value upper limit, Serum creatinine >177 µmmol/L (2mg/dL), or liver cirrhosis;
  • subjects with carotid stenosis or systolic murmur
  • subjects with a history of unstable angina pectoris, acute mycardial infarction, percutaneous transluminal coronary angiography or coronary artery bypass grafting in the past 6 months;
  • subjects who were within lactation period, pregnant, or planning to become pregnant during the study;
  • hypersensitive to Nifedipine GITS or with SAE;
  • subjects who are participating in other clinical trials;
  • considered not fit for the study due to other reasons according to the researchers (such as Malignant tumor, psyche or nervous system dysfunction, or special diseases).

Sites / Locations

  • Division of Cardiology, Peking University First HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nifedipine GITS

Arm Description

Outcomes

Primary Outcome Measures

Control rate of hypertension evaluated by office blood pressure at 8 weeks
Control rate of hypertension evaluated by office blood pressure at 4 weeks
Control rate of hypertension evaluated by office blood pressure at 2 weeks

Secondary Outcome Measures

Control rate of hypertension evaluated by 24-hour ABPM at 8 weeks
Change of office blood pressure from baseline to 8 weeks
Change of 24-hour ABPM from baseline to 8 weeks

Full Information

First Posted
December 18, 2015
Last Updated
March 20, 2019
Sponsor
Peking University First Hospital
Collaborators
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT02641821
Brief Title
Effect of Nifedipine GITS in Patients With Mild-to-moderate Primary Hypertension
Official Title
Effect of Nifedipine GITS in Patients With Mild-to-moderate Primary Hypertension: a Multi-center, Open-label, Observational Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 2015 (undefined)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University First Hospital
Collaborators
Bayer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a multi-center, open-label, observational study. The aim of this study is to evaluate the efficacy of Nifedipine GITS on lowering blood pressure in Chinese adults with mild-to-moderate hypertension.
Detailed Description
The primary aim of the study is to evaluate the efficacy of nifedipine gastrointestinal therapeutic system (GITS) on lowering blood pressure in Chinese adults with mild-to-moderate hypertension. The secondary aim of the study is to evaluate the efficacy of Nifedipine GITS on lowering blood pressure in hypertensive patients with different urinary sodium levels. Based on sample size estimation, the plan is to recruit 700 patients from 16 centers. At baseline, patients'demographic characters, disease history and anthropometric indices will be collected, laboratory tests will be performed for blood routine examination, urinalysis, renal function, hepatic function, urinary sodium and 24-hour urinary sodium. All eligible patients will be assigned to a treatment of Nifedipine GITS and followed up for 8 weeks. At 0 day, 2,weeks, 4 weeks and 8 weeks of the study, seated blood pressure, vital signs, medication and adverse events were collected. At the end of the study, 24-hour ambulatory blood pressure monitoring (ABPM) will be performed for all participants.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
700 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nifedipine GITS
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Nifedipine GITS
Primary Outcome Measure Information:
Title
Control rate of hypertension evaluated by office blood pressure at 8 weeks
Time Frame
8 weeks
Title
Control rate of hypertension evaluated by office blood pressure at 4 weeks
Time Frame
4 weeks
Title
Control rate of hypertension evaluated by office blood pressure at 2 weeks
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Control rate of hypertension evaluated by 24-hour ABPM at 8 weeks
Time Frame
8 weeks
Title
Change of office blood pressure from baseline to 8 weeks
Time Frame
8 weeks
Title
Change of 24-hour ABPM from baseline to 8 weeks
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: a seated systolic BP (SBP) ≥140 mmHg and <180 mmHg and/or a seated diastolic BP (DBP) ≥90 mmHg and <110 mmHg; an age ≥18 and ≤75 years; those who had not taken any BP-lowering medications in 1 month before the study. Exclusion Criteria: a seated systolic BP (SBP) ≥180 mmHg and/or a seated diastolic BP ≥110 mmHg; secondary hypertension; diagnosed heart failure or stroke; Any of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) was above 1.5 times of it's normal value upper limit, Serum creatinine >177 µmmol/L (2mg/dL), or liver cirrhosis; subjects with carotid stenosis or systolic murmur subjects with a history of unstable angina pectoris, acute mycardial infarction, percutaneous transluminal coronary angiography or coronary artery bypass grafting in the past 6 months; subjects who were within lactation period, pregnant, or planning to become pregnant during the study; hypersensitive to Nifedipine GITS or with SAE; subjects who are participating in other clinical trials; considered not fit for the study due to other reasons according to the researchers (such as Malignant tumor, psyche or nervous system dysfunction, or special diseases).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yang Yu, MD
Phone
8610-83575262
Email
jiyou_2000@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yong Huo, MD
Organizational Affiliation
Peking University First Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of Cardiology, Peking University First Hospital
City
Beijing
ZIP/Postal Code
100034
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yang Yu
Phone
8610-83575262
Email
jiyou_2000@163.com
First Name & Middle Initial & Last Name & Degree
Yong Huo, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Effect of Nifedipine GITS in Patients With Mild-to-moderate Primary Hypertension

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