NCT01091753

Brief Summary

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

  1. 1.ECHO
  2. 2.24hr. horter
  3. 3.IMT
  4. 4.BUN/crea, urine analysis (microalbulinuria
  5. 5.Cardio vascular event. "

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for phase_4 hypertension

Timeline
Completed

Started Mar 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 23, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 24, 2010

Completed
Last Updated

October 8, 2010

Status Verified

October 1, 2010

Enrollment Period

1.2 years

First QC Date

March 23, 2010

Last Update Submit

October 7, 2010

Conditions

Hypertension

Keywords

Non-dipper HTN patient

Outcome Measures

Primary Outcomes (2)

  • IMT(intima media thickness) Measure data(Sono)

    baseline

  • IMT(intima media thickness) Measure data(Sono)

    36 months

Study Arms (2)

morning administration group

PLACEBO COMPARATOR
Drug: Valsaltan, amlodipine

nocturnal administration group

EXPERIMENTAL
Drug: Valsaltan, amlodipine

Interventions

Valsaltan, amlodipineDRUG

nti hypertensive medication time (nocturnal administration vs morning administration

morning administration groupnocturnal administration group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Any known malignant disease
  • Renal failure , creatinine \>2.0mg/dl
  • Liver disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance Hospital, Yonsei University College of Medicine

Seoul, South Korea

Location

MeSH Terms

Conditions

Hypertension

Interventions

Amlodipine

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

DihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Dong hun Choi

    professor of division of Cardiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 23, 2010

First Posted

March 24, 2010

Study Start

March 1, 2008

Primary Completion

May 1, 2009

Study Completion

September 1, 2009

Last Updated

October 8, 2010

Record last verified: 2010-10

Locations

KR(1)