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

This study has been completed.
Sponsor:
Information provided by:
Yonsei University
ClinicalTrials.gov Identifier:
NCT01091753
First received: March 23, 2010
Last updated: October 7, 2010
Last verified: October 2010
  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: 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 ] [ Designated as safety issue: No ]
  • IMT(intima media thickness) Measure data(Sono) [ Time Frame: 36 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: March 23, 2010
Last Updated: October 7, 2010
Health Authority: Korea: Food and Drug Administration

Keywords provided by Yonsei University:
Non-dipper HTN patient

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Amlodipine
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents

ClinicalTrials.gov processed this record on July 26, 2014