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Trial record 17 of 71 for:    TELMISARTAN AND HYDROCHLOROTHIAZIDE

Comparison of the Medication Adherence of Patients Treated With Telmisartan/Hydrochlorothiazide or Telmisartan/Amlodipine Fixed Dose Combination (FDC) Versus Double-pill Combination Therapy in Real-world Japanese Therapeutic Practice

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ClinicalTrials.gov Identifier: NCT03205137
Recruitment Status : Not yet recruiting
First Posted : July 2, 2017
Last Update Posted : November 13, 2019
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
The primary objective of this study is to compare the medication adherence measured by PDC of patients with FDC or double-pill combination therapy in real-world Japanese therapeutic practice.The further objective of this study is how much influence the background of patients to the adherence.

Condition or disease Intervention/treatment
Hypertension Drug: subjects treated with telmisartan/hydrochlorothiazide Drug: Subjects treated with Telmisartan and amlodipine Drug: subjects treated with Telmisartan+hydrochlorothiazide double-pill combination group Drug: subjects treated with telmisartan+amlodipine double pill

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Study Type : Observational
Estimated Enrollment : 3275 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Comparison of the Medication Adherence of Patients Treated With Telmisartan/Hydrochlorothiazide or Telmisartan/Amlodipine FDC Versus Double-pill Combination Therapy in Real-world Japanese Therapeutic Practice
Estimated Study Start Date : December 23, 2019
Estimated Primary Completion Date : January 27, 2020
Estimated Study Completion Date : January 27, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Telmisartan and hydrochlorothiazide group Drug: subjects treated with telmisartan/hydrochlorothiazide
subjects treated with telmisartan/hydrochlorothiazide
Other Name: MICARDIS, PRITOR, TELMISARTAN

Telmisartan and amlodipine group Drug: Subjects treated with Telmisartan and amlodipine
Subjects treated with Telmisartan and amlodipine
Other Name: MICARDIS, PRITOR, TELMISARTAN

Telmisartan+hydrochlorothiazide double-pill combination group Drug: subjects treated with Telmisartan+hydrochlorothiazide double-pill combination group
subjects treated with Telmisartan+hydrochlorothiazide double-pill combination group
Other Name: MICARDIS, PRITOR, TELMISARTAN

telmisartan+amlodipine double-pill combination group Drug: subjects treated with telmisartan+amlodipine double pill
subjects treated with telmisartan+amlodipine double pill
Other Name: MICARDIS, PRITOR, TELMISARTAN




Primary Outcome Measures :
  1. Proportion of days covered of patients treated with single- and double- combination therapy [ Time Frame: 180 days ]

Secondary Outcome Measures :
  1. Demographic and clinical characteristics of patients treated with single- and double combination [ Time Frame: 180 days ]


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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Japan Medical Information Research Institute (JMIRI), Inc. prescription database is used.
Criteria

Inclusion Criteria:

  • Patients with hypertension
  • Patients must have their first prescription (defined as index date*) for telmisartan and hydrochlorothiazide or Micombi® between 01/07/2010 and 28/09/2010
  • Patients must have their first prescription (defined as index date*) for telmisartan and amlodipine or Micamlo® between 10/12/2010 and 09/03/2011
  • Patients must have at least 180 days follow up verified by the presence of prescription record

Exclusion Criteria:

  • Patients who were under 40 years old at the time of enrolment
  • Patients who prescribed the study drugs less than 90 days during a follow up period of 180 days
  • Patients whose visits are less than 2 times during a follow up period of 180 days

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): NCT03205137


Contacts
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Contact: Boehringer Ingelheim 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

Sponsors and Collaborators
Boehringer Ingelheim

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT03205137     History of Changes
Other Study ID Numbers: 0502-0612
First Posted: July 2, 2017    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Hydrochlorothiazide
Telmisartan
Telmisartan amlodipine combination
Telmisartan, hydrochlorothiazide drug combination
Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Diuretics
Natriuretic Agents
Sodium Chloride Symporter Inhibitors
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists