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Trial record 19 of 144 for:    NIFEDIPINE

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

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ClinicalTrials.gov Identifier: NCT02641821
Recruitment Status : Recruiting
First Posted : December 29, 2015
Last Update Posted : March 22, 2019
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Yong Huo, Peking University First Hospital

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.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Nifedipine GITS Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 700 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Nifedipine GITS in Patients With Mild-to-moderate Primary Hypertension: a Multi-center, Open-label, Observational Study
Study Start Date : October 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Nifedipine

Arm Intervention/treatment
Experimental: Nifedipine GITS Drug: Nifedipine GITS



Primary Outcome Measures :
  1. Control rate of hypertension evaluated by office blood pressure at 8 weeks [ Time Frame: 8 weeks ]
  2. Control rate of hypertension evaluated by office blood pressure at 4 weeks [ Time Frame: 4 weeks ]
  3. Control rate of hypertension evaluated by office blood pressure at 2 weeks [ Time Frame: 2 weeks ]

Secondary Outcome Measures :
  1. Control rate of hypertension evaluated by 24-hour ABPM at 8 weeks [ Time Frame: 8 weeks ]
  2. Change of office blood pressure from baseline to 8 weeks [ Time Frame: 8 weeks ]
  3. Change of 24-hour ABPM from baseline to 8 weeks [ Time Frame: 8 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

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): NCT02641821


Contacts
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Contact: Yang Yu, MD 8610-83575262 jiyou_2000@163.com

Locations
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China
Division of Cardiology, Peking University First Hospital Recruiting
Beijing, China, 100034
Contact: Yang Yu    8610-83575262    jiyou_2000@163.com   
Principal Investigator: Yong Huo, MD         
Sponsors and Collaborators
Peking University First Hospital
Bayer
Investigators
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Principal Investigator: Yong Huo, MD Peking University First Hospital

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Responsible Party: Yong Huo, Director, Department of Cardiology, Peking University First Hospital
ClinicalTrials.gov Identifier: NCT02641821     History of Changes
Other Study ID Numbers: Nifedipine-HT-1.0
First Posted: December 29, 2015    Key Record Dates
Last Update Posted: March 22, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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