Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Azilsartan/Amlodipine Combination Tablets LD & HD Specified Drug-use Survey "Long-term Use Survey"

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.
ClinicalTrials.gov Identifier: NCT02181816
Recruitment Status : Completed
First Posted : July 4, 2014
Results First Posted : June 3, 2019
Last Update Posted : June 3, 2019
Sponsor:
Information provided by (Responsible Party):
Takeda

Brief Summary:
The purpose of this survey is to evaluate the safety and efficacy of long-term use of azilsartan/amlodipine combination tablets Low Dose (LD) & High Dose (HD) (Zacras Combination Tablets LD & HD) in hypertensive patients in daily medical practice.

Condition or disease Intervention/treatment
Hypertension Drug: Azilsartan/Amlodipine

Detailed Description:

This survey was designed to evaluate the safety and efficacy of long-term use of azilsartan/amlodipine combination tablets LD & HD (Zacras Combination Tablets LD & HD) in hypertensive patients in daily medical practice.

For adults, one azilsartan/amlodipine combination tablet (20 mg/2.5 mg [for LD tablets] or 20 mg/5 mg [for HD tablets] of azilsartan/amlodipine) is administered orally once daily. Azilsartan/amlodipine combination tablets should not be used as the first-line drug for the treatment of hypertension.


Layout table for study information
Study Type : Observational
Actual Enrollment : 1090 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Azilsartan/Amlodipine (Zacras) Combination Tablets LD & HD Specified Drug-use Survey "Long-term Use Survey"
Actual Study Start Date : June 26, 2014
Actual Primary Completion Date : January 31, 2017
Actual Study Completion Date : January 31, 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Azilsartan/Amlodipine
Azilsartan/Amlodipine combination tablets (20 mg/2.5 mg or 20 mg/5 mg), orally, once daily for up to 12 months. Participants will receive interventions as part of routine medical care.
Drug: Azilsartan/Amlodipine
Azilsartan/Amlodipine combination tablets LD & HD
Other Name: Zacras Combination Tablets LD & HD




Primary Outcome Measures :
  1. Percentage of Participants Who Had One or More Adverse Events [ Time Frame: Up to Month 12 ]

Secondary Outcome Measures :
  1. Systolic Office Blood Pressure [ Time Frame: Baseline, Month 1, and final assessment point (up to Month 12) ]
    Systolic office blood pressure level at baseline, Month 1, and the final assessment point (up to Month 12) were reported.

  2. Diastolic Office Blood Pressure [ Time Frame: Baseline, Month 1, and final assessment point (up to Month 12) ]
    Diastolic office blood pressure level at baseline, Month 1, and the final assessment point (up to Month 12) were reported.



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.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Hypertension
Criteria

Inclusion Criteria:

-Hypertensive patients

Exclusion Criteria:

-Hypertensive patients who meet any of the following conditions, [1] to [3], are excluded from the survey:

  1. Patients with a history of hypersensitivity to any of the ingredients of azilsartan/amlodipine combination tablets or other dihydropyridine drugs
  2. Patients who are pregnant or having possibilities of being pregnant
  3. Diabetic patients taking aliskiren fumarate (excluding those with markedly poor blood pressure control even after other antihypertensive treatment)

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): NCT02181816


Locations
Layout table for location information
Japan
Osaka, Japan
Tokyo, Japan
Sponsors and Collaborators
Takeda
Investigators
Layout table for investigator information
Study Director: Study Director Takeda
  Study Documents (Full-Text)

Documents provided by Takeda:
Study Protocol  [PDF] June 2, 2017
Statistical Analysis Plan  [PDF] November 29, 2017


Layout table for additonal information
Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT02181816     History of Changes
Other Study ID Numbers: 212-011
JapicCTI-142592 ( Registry Identifier: JapicCTI )
First Posted: July 4, 2014    Key Record Dates
Results First Posted: June 3, 2019
Last Update Posted: June 3, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Takeda:
Pharmacological therapy

Additional relevant MeSH terms:
Layout table for MeSH terms
Amlodipine
Azilsartan medoxomil
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists