NCT00288717

Brief Summary

To investigate the effects of Candesartan and Telmisartan on the home blood pressure, glucose and lipid-metabolism in the hypertensive patients with the accumulation of visceral fat by the newly developed Tele-medicine system

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P50-P75 for not_applicable hypertension

Timeline
Completed

Started Feb 2006

Geographic Reach
1 country

1 active site

Status
unknown

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

February 1, 2006

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

February 7, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 8, 2006

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

January 11, 2007

Status Verified

January 1, 2007

First QC Date

February 7, 2006

Last Update Submit

January 9, 2007

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

  • Home blood pressure in the early morning

Secondary Outcomes (18)

  • Home blood pressure at bedtime

  • M/E ratio

  • Casual blood pressure

  • Body fat percentage

  • Body weight

  • +13 more secondary outcomes

Interventions

CandesartanDRUG
TelmisartanDRUG

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Circumference at waist: male ≧85 cm, female ≧90 cm
  • Hypertensive patient with untreated hypertension, and casual blood pressure of systole ≧140 mmHg, or diastole ≧90 mmHg
  • Hypertensive patient with hypertension under treatment, and casual blood pressure of systole ≧130 mmHg, or diastole ≧85 mmHg

You may not qualify if:

  • Significant hypertensive patient with diastolic blood pressure ≧120 mmHg
  • Malignant hypertensive patient
  • Patient with a contraindication to the study drugs (hypersensitivity, significant hepatic diseases, pregnant woman)
  • Patient with urinary protein (qualitative) ＋～＋＋
  • Patient with familial hyperlipidemia
  • Other patients judged as ineligible for the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saitama Medical School Department of Renal Medicine

Saitama, Saitama, 350-0495, Japan

RECRUITING

MeSH Terms

Conditions

Hypertension

Interventions

candesartanTelmisartan

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Hidetomo Nakamoto, MD

    Saitama Medical School Department of Renal Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hidetomo Nakamoto, MD

CONTACT

+81-0492-76-1258nakamo_h@saitama-med.ac.jp

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 7, 2006

First Posted

February 8, 2006

Study Start

February 1, 2006

Study Completion

September 1, 2007

Last Updated

January 11, 2007

Record last verified: 2007-01

Locations

JP(1)