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Effectiveness of Candesartan and Telmisartan on Morning Hypertension in Japanese Obese Patients

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ClinicalTrials.gov Identifier: NCT00288717
Recruitment Status : Unknown
Verified January 2007 by Saitama Medical University.
Recruitment status was:  Recruiting
First Posted : February 8, 2006
Last Update Posted : January 11, 2007
Sponsor:
Collaborator:
Non-Profit Organaizaion "LINE"
Information provided by:
Saitama Medical University

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

Condition or disease Intervention/treatment Phase
Hypertension Drug: Candesartan Drug: Telmisartan Not Applicable

Detailed Description:
A randomized, comparative study of 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 central registration system

Study Type : Interventional  (Clinical Trial)
Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: A Randomized, Comparative Study of 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 Central Registration System
Study Start Date : February 2006
Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Home blood pressure in the early morning

Secondary Outcome Measures :
  1. Home blood pressure at bedtime
  2. M/E ratio
  3. Casual blood pressure
  4. Body fat percentage
  5. Body weight
  6. Height
  7. BMI
  8. Blood potassium
  9. Total cholesterol
  10. HDL cholesterol
  11. LDL cholesterol
  12. Triglyceride
  13. Blood glucose
  14. IRI
  15. HbAlc*
  16. HOMA-IR
  17. Urinary trace albumin
  18. Creatinine


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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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): NCT00288717


Contacts
Contact: Hidetomo Nakamoto, MD +81-0492-76-1258 nakamo_h@saitama-med.ac.jp

Locations
Japan
Saitama Medical School Department of Renal Medicine Recruiting
Saitama City, Saitama, Japan, 350-0495
Contact: Hidetomo Nakamoto, MD    +81-492-76-1258    nakamo_h@saitama-med.ac.jp   
Principal Investigator: Hidetomo Nakamoto, MD         
Sponsors and Collaborators
Saitama Medical University
Non-Profit Organaizaion "LINE"
Investigators
Principal Investigator: Hidetomo Nakamoto, MD Saitama Medical School Department of Renal Medicine

ClinicalTrials.gov Identifier: NCT00288717     History of Changes
Other Study ID Numbers: FUJIYAMA-Study
UMIN-CTR-C000000324
First Posted: February 8, 2006    Key Record Dates
Last Update Posted: January 11, 2007
Last Verified: January 2007

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Telmisartan
Candesartan
Candesartan cilexetil
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action