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Trial record 10 of 143 for:    NIFEDIPINE

Nifedipine GITS and Amlodipine Besylate on Recovery of Blood Pressure Rhythm and Arterial Stiffness (NARRAS)

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ClinicalTrials.gov Identifier: NCT02940548
Recruitment Status : Unknown
Verified December 2016 by Jing Liu, Peking University People's Hospital.
Recruitment status was:  Recruiting
First Posted : October 21, 2016
Last Update Posted : December 14, 2016
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Jing Liu, Peking University People's Hospital

Brief Summary:
This trial evaluates the effects of Nifedipine GITS and Amlodipine besylate on blood pressure rhythm restoration and arterial stiffness in young and middle-aged non-dipper hypertensives. Half of participants will receive Nifedipine GITS, half of half will take medicine in the morning or at night. While the other half participants will take amlodipine besylate, whom will also be assigned taking medicine in the morning or at night. Ambulatory blood pressure monitoring and arterial stiffness examination will be performed before and after pharmaceutical intervention.

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

Detailed Description:

Written informed consent will obtained from all the participants. All the adverse reaction or adverse event, related or unrelated to the study drug, will be recorded in detail, including the occurrence time, symptoms and vital signs, degree, duration, laboratory test indexes, treatment methods and results, process, follow-up time, etc.

If serious adverse event occurs, study drugs should be stopped and necessary remedy should be delivered immediately. At the same time, the investigator must report it to the local drug supervision, medical ethics committee and China Food and Drug Administration.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Comparative Study for the Effects of Nifedipine GITS and Amlodipine Besylate on Recovery of Blood Pressure Rhythm and Arterial Stiffness in the Young and Middle-aged Subjects With Non-dipper Hypertension
Study Start Date : December 2016
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Nifedipine GITS
Nifedipine GITS 30~60mg/day
Drug: Nifedipine GITS
Nifedipine GITS 30~60mg/day for 8 weeks
Other Name: Adalat

Active Comparator: Amlodipine besylate
Amlodipine besylate 5~10mg/day
Drug: Amlodipine besylate
Amlodipine besylate 5~10mg/day for 8 weeks
Other Name: Norvasc




Primary Outcome Measures :
  1. Nighttime systolic blood pressure reduction [ Time Frame: 8 weeks ]
    Compare the effects of two active drugs on nighttime systolic blood pressure reduction


Secondary Outcome Measures :
  1. The proportion of recovery of dipper rhythm of blood pressure [ Time Frame: 8 weeks ]
    Compare the effects of two active drugs and different time administration on recovery of dipper rhythm. The proportion of blood pressure dipper rhythm at 8 weeks after two drugs administration will be calculated. The proportion of dipper rhythm at 8 weeks after two drugs administration in the morning or at night will also be calculated.

  2. Change of pulse wave velocity [ Time Frame: 8 weeks ]
    Compare the effects of two active drugs on pulse wave velocity(PWV). PWV will be measured before and after 8 weeks two active drugs administration.


Other Outcome Measures:
  1. Incidence of treatment-related adverse events [ Time Frame: 8 weeks ]
    change of heart rate; change of liver and kidney function; other adverse reactions, such as edema, flushing, etc during 8 weeks of intervention and follow-ups



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Mild to moderate (Office blood pressure : 140 mmHg =< systolic blood pressure (SBP) <180 mmHg and / or 90 mmHg =< diastolic blood pressure (DBP) <110 mmHg) , non-dipper (ambulatory blood pressure monitoring (ABPM): night-time mean SBP / day-time mean SBP >=0.9 and night-time mean SBP >=120 mmHg) hypertensive subjects, who is drug treatment-naive or previously treated but discontinued for 2 weeks or more
  • The subject is voluntary to participate in the study and has signed the informed consent form

Exclusion Criteria:

  • Known allergy to any component of Nifedipine and Amlodipine
  • Office SBP >=180 mmHg and / or DBP >=110 mmHg in the screening period
  • The patient who is taking calcium antagonists (monotherapy or combination with other drugs)
  • Evidences of secondary hypertension
  • History of cerebrovascular events, cardiac failure, serious coronary artery disease within 12 months
  • Type 1 diabetes mellitus (DM)
  • Severe liver diseases or renal insufficiency
  • The pregnant woman, the woman who may be pregnant or plan to be pregnant, or the lactating woman
  • The subject who needs to work at night (on night shift)
  • Other reasons that the subject can not participate in the study

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): NCT02940548


Contacts
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Contact: Jing Liu, M.D. 861088325457 heartcenter@163.com

Locations
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China
Peking University People's Hospital Recruiting
Beijing, China, 100044
Contact: Jing Liu, M.D.    861088325457    heartcenter@163.com   
Principal Investigator: Jing Liu, M.D.         
Sponsors and Collaborators
Jing Liu
Bayer
Investigators
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Principal Investigator: Jing Liu, M.D. Peking University People's Hospital

Publications:
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Responsible Party: Jing Liu, Chief Physician, Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT02940548     History of Changes
Other Study ID Numbers: 2016PHB013-02
First Posted: October 21, 2016    Key Record Dates
Last Update Posted: December 14, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Jing Liu, Peking University People's Hospital:
non-dipper hypertension
young
middle-aged
ambulatory blood pressure monitoring
arterial stiffness
nifedipine gastrointestinal therapeutic system (GITS)
Additional relevant MeSH terms:
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Nifedipine
Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Antihypertensive Agents
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