Blopress Tablets Specified Drug-use Survey "Hypertension: Survey on Patients With Metabolic Syndrome"

NCT02166697 | Completed Results

• 3 other identifiers: 460-015JapicCTI-142567JapicCTI-R160847
• Study Type: observational
• Target: 14,151
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this survey is designed to investigate the treatment status of hypertensive patient with metabolic syndrome-related risk factors treated with candesartan cilexetil tablets (Blopress Tablets), as well as to assess relationships between risk factors (example, visceral fat accumulation) and the incidence of cerebrovascular/cardiovascular events in an exploratory manner.

Conditions

Hypertension

Keywords

Pharmacological therapy

Outcome Measures

Primary Outcomes (2)

• Number of Participants Reporting One or More Adverse Drug Reactions (ADR)

  ADR are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.

  Baseline up to 3 years

• Number of Participants Reporting One or More Serious Adverse Drug Reactions (SADR)

  SADR are defined as serious adverse events (SAEs) which are in the investigator's opinion of causal relationship to the study treatment. SADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

  Baseline up to 3 years

Secondary Outcomes (4)

• Incidence of Cerebrovascular/Cardiovascular Events

  Baseline up to 3 years

• Incidence of Cerebrovascular/Cardiovascular Events Affected by Underlying Risk Factors of Obesity, Blood Glucose Abnormalities, or Lipid Abnormalities

  Baseline up to 3 years

• Incidence of Cerebrovascular/Cardiovascular Events Affected by Underlying Risk Factors of Obesity + Blood Glucose Abnormalities, Obesity + Lipid Abnormalities, or Blood Glucose Abnormalities + Lipid Abnormalities

  Baseline up to 3 years

• Incidence of Cerebrovascular/Cardiovascular Events Affected by Underlying Risk Factors of Obesity + Blood Glucose Abnormalities + Lipid Abnormalities

  Baseline up to 3 years

Study Arms (1)

Oral administration of 4-8 mg of candesartan cilexetil

Oral administration of 4-8 milligram (mg) of candesartan cilexetil once daily (increased up to 12 mg, as necessary)

Drug: candesartan cilexetil

Interventions

candesartan cilexetil DRUG

candesartan cilexetil tablets

Also known as: Blopress Tablets

Oral administration of 4-8 mg of candesartan cilexetil

Eligibility Criteria

• Age: 20 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hypertension

You may qualify if:

• Waist circumference greater than or equal to (≥) 85 centimeter (cm) for male and ≥ 90 cm for female
• Fasting triglyceride level ≥ 150 milligram per deciliter (mg/dL)
• High-density lipoprotein (HDL) cholesterol level less than (\<) 40 mg/dL
• Fasting blood glucose level ≥ 110 mg/dL

You may not qualify if:

• Patients receiving continuous therapy with Blopress Tablets
• Patients aged \< 20 years or ≥ 75 years
• Patients with a history of cerebrovascular or coronary artery disease within 6 months before the start of the surveillance

Sponsors & Collaborators

• Takeda: lead

MeSH Terms

Conditions

Hypertension

Interventions

candesartan cilexetil

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Medical Director
• Organization: Takeda

trialdisclosures@takeda.com

+1-877-825-3327

Study Officials

• Postmarketing Group Manager

  Takeda

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2014
• First Posted: June 18, 2014
• Study Start: June 1, 2006
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: September 28, 2016
• Results First Posted: July 11, 2016

Record last verified: 2016-09