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Effect of Nocturnal Administration of Anti-hypertensive Medications in NoN-dippers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01091753
First Posted: March 24, 2010
Last Update Posted: October 8, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Yonsei University
  Purpose

The purpose of this study is to determine the effect of nocturnal administration of Anti-hypertensive medications in Non-dippers.

Efficacy variables.

  1. ECHO
  2. 24hr. horter
  3. IMT
  4. BUN/crea, urine analysis (microalbulinuria
  5. Cardio vascular event. "

Condition Intervention Phase
Hypertension Drug: Valsaltan, amlodipine Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Nocturnal Administration of Anti-hypertensive Medications in NoN-dippers

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • IMT(intima media thickness) Measure data(Sono) [ Time Frame: baseline ]
  • IMT(intima media thickness) Measure data(Sono) [ Time Frame: 36 months ]

Enrollment: 28
Study Start Date: March 2008
Study Completion Date: September 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: morning administration group Drug: Valsaltan, amlodipine
nti hypertensive medication time (nocturnal administration vs morning administration
Experimental: nocturnal administration group Drug: Valsaltan, amlodipine
nti hypertensive medication time (nocturnal administration vs morning administration

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Essential hypertension (stage 1-2)
  2. 24hr. holer : non-dipper
  3. Age 18 ~70.

Exclusion Criteria:

  1. Any known malignant disease
  2. Renal failure , creatinine >2.0mg/dl
  3. Liver disease
  Contacts and Locations
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): NCT01091753


Locations
Korea, Republic of
Severance Hospital, Yonsei University College of Medicine
Seoul, Korea, Republic of
Sponsors and Collaborators
Yonsei University
Investigators
Principal Investigator: Dong hun Choi professor of division of Cardiology
  More Information

Responsible Party: Choi, Dong hun/professor, Yonsei University, College of Medicine
ClinicalTrials.gov Identifier: NCT01091753     History of Changes
Other Study ID Numbers: 4-2007-0440
First Submitted: March 23, 2010
First Posted: March 24, 2010
Last Update Posted: October 8, 2010
Last Verified: October 2010

Keywords provided by Yonsei University:
Non-dipper HTN patient

Additional relevant MeSH terms:
Amlodipine
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents