An Observational Study to Describe the Effectiveness of Angiotensin Converting Enzyme Inhibitor and Calcium Channel Blocker Combination in the Management of Hypertensive Patients With Elevated Heart Rate and Type 2 Diabetes

NCT ID: NCT02298556

Last Updated: 2018-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

270 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-10-31

Study Completion Date

2016-03-08

Brief Summary

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To describe the effectiveness of angiotensin-converting enzyme inhibitor and non-dihydropyridine calcium channel blocker single pill combination on systolic blood pressure (SBP) lowering in hypertensive patients with elevated heart rate and type 2 diabetes

Detailed Description

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Conditions

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Hypertension

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Hypertensive patients

Hypertensive patients with elevated heart rate and type 2 diabetes mellitus

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Male or female
* ≥ 18 years old
* Has been already diagnosed with hypertension
* Has been already diagnosed with type 2 diabetes mellitus
* Started using angiotensin-converting enzyme inhibitor and non-dihydropyridine calcium channel blocker single pill combination within a maximum of 1 week before enrolment
* Heart rate ≥70 beat per minute

Exclusion Criteria

* Pregnant or breast feeding female
* Current need to use any other antihypertensive drug(s) in addition to angiotensin-converting enzyme inhibitor and non-dihydropyridine calcium channel blocker single pill combination
* Having any contraindication for angiotensin-converting enzyme inhibitor or non-dihydropyridine calcium channel blocker;
* Has been treated by any anti-hypertensive treatment(s) before angiotensin-converting enzyme inhibitor and non-dihydropyridine calcium channel blocker single pill combination
* Is currently participating in another clinical or non-clinical study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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MonitorCRO

INDUSTRY

Sponsor Role collaborator

Abbott

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Enver Atalar, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University Faculty of Medicine Hospital Cardiology Clinic

Locations

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Research facility ID ORG-001108

Adana, , Turkey (Türkiye)

Site Status

Research facility ID ORG-001030

Ankara, , Turkey (Türkiye)

Site Status

Yıldırım Beyazıt University Yenimahalle Training and Research Hospital

Ankara, , Turkey (Türkiye)

Site Status

Research facility ID ORG-001111

Antalya, , Turkey (Türkiye)

Site Status

Research facility ID ORG-001120

Aydin, , Turkey (Türkiye)

Site Status

Research facility ID ORG-001119

Aydin, , Turkey (Türkiye)

Site Status

Research facility ID ORG-001116

Balıkesir, , Turkey (Türkiye)

Site Status

Research facility ID ORG-001112

Burdur, , Turkey (Türkiye)

Site Status

Research facility ID ORG-001123

Çorum, , Turkey (Türkiye)

Site Status

Erzurum Regional Training and Research Hospital

Erzurum, , Turkey (Türkiye)

Site Status

Atatürk University Aziziye Research Hospital

Erzurum, , Turkey (Türkiye)

Site Status

Research facility ID ORG-001118

Istanbul, , Turkey (Türkiye)

Site Status

Bakırköy Dr. Sadi Konuk Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Research facility ID ORG-001117

Istanbul, , Turkey (Türkiye)

Site Status

Dr. Siyami Ersek Göğüs Kalp ve Damar Cerrahisi Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Research facility ID ORG-001125

Istanbul, , Turkey (Türkiye)

Site Status

Research facility ID ORG-001113

Karabük, , Turkey (Türkiye)

Site Status

Research facility ID ORG-001110

Konya, , Turkey (Türkiye)

Site Status

Research facility ID ORG-001115

Kırıkkale, , Turkey (Türkiye)

Site Status

Research facility ID ORG-001122

Trabzon, , Turkey (Türkiye)

Site Status

Uskudar PublicHospital

Üsküdar, , Turkey (Türkiye)

Site Status

Yalova Public Hospital

Yalova, , Turkey (Türkiye)

Site Status

Research facility ID ORG-001124

Zonguldak, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Atalar E, Eskin F, Tugtekin HB, Karabulut A, Kanyilmaz S, Kirbiyik H, Ozyildiz AG. A Prospective Noninterventional, Observational Study to Describe the Effectiveness and Safety of Trandolapril and Verapamil Single-Pill Combination in the Management of Patients with Hypertension and Type 2 Diabetes Mellitus: A Harvest TR Study. Biomed Res Int. 2020 Sep 5;2020:2123601. doi: 10.1155/2020/2123601. eCollection 2020.

Reference Type DERIVED
PMID: 32964020 (View on PubMed)

Other Identifiers

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GSS-13-0019

Identifier Type: -

Identifier Source: org_study_id

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