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Trial record 1 of 1 for:    119-011
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Candesartan Cilexetil/Amlodipine Combination Tablets LD, HD Special Drug Use Surveillance "Hypertension: Long-Term Use"

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02068495
First Posted: February 21, 2014
Last Update Posted: February 21, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Takeda
  Purpose
This study will investigate the safety and efficacy of long-term use of candesartan cilexetil/amlodipine combination tablets (Unisia Combination Tablets) LD, HD in patients with hypertension in the normal clinical setting.

Condition Intervention
Hypertension Drug: Candesartan cilexetil/amlodipine

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Unisia Combination Tablets LD, HD Special Drug Use Surveillance "Hypertension: Long-Term Use"

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • Frequency of adverse events and adverse drug reactions [ Time Frame: 12 months from the baseline ]
    Frequency, severity, and time to onset of adverse events and adverse drug reactions tabulated by each symptom. Adverse events 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. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions..


Secondary Outcome Measures:
  • Changes in blood pressure, achievement rate of the target blood pressure levels [ Time Frame: 12 months from baseline ]
    Calculation of summary statistics for actual measurement values and the change from baseline in systolic and diastolic blood pressure.


Enrollment: 3409
Study Start Date: June 2010
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Candesartan cilexetil/amlodipine
8 mg/2.5 mg or 8 mg/5 mg, orally, once daily
Drug: Candesartan cilexetil/amlodipine
Candesartan cilexetil/amlodipine tablets
Other Name: Unisia Combination Tablets

Detailed Description:

This special drug use surveillance was designed to investigate the safety and efficacy of long-term use of candesartan cilexetil/amlodipine combination tablets (Unisia Combination Tablets) in patients with hypertension in the routine clinical setting.

The usual adult dosage is one tablet (8 mg/2.5 mg or 8 mg/5 mg as candesartan cilexetil/amlodipine) administered orally once daily.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hypertension
Criteria

Inclusion Criteria:

  • Patients with hypertension

Exclusion Criteria:

  • Patients in whom Unisia is contraindicated [Contraindications]

    1. Patients with a history of hypersensitivity to the ingredients of Unisia or any other dihydropyridine formulations
    2. Women who are pregnant or of child-bearing potential
  Contacts and Locations
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): NCT02068495


Sponsors and Collaborators
Takeda
Investigators
Study Chair: Postmarketing Group Manager Takeda
  More Information

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT02068495     History of Changes
Other Study ID Numbers: 119-011
JapicCTI-132390 ( Registry Identifier: JapicCTI )
First Submitted: February 19, 2014
First Posted: February 21, 2014
Last Update Posted: February 21, 2014
Last Verified: February 2014

Keywords provided by Takeda:
Drug therapy

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Candesartan
Candesartan cilexetil
Amlodipine
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists