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

NCT02298556 | Completed

• 1 other identifier: GSS-13-0019
• Study Type: observational
• Target: 270
• Locations: 1 country
• Sites: 23

Brief Summary

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

Conditions

Hypertension

Keywords

Hypertension; Diabetes Mellitus; ACE Inhibitors; Calcium Channel Blockers

Outcome Measures

Primary Outcomes (1)

• Absolute change in systolic blood pressure

  mmHg

  from baseline to week 8

Secondary Outcomes (11)

• Absolute change in diastolic blood pressure (DBP)

  from baseline to week 8

• Ratio of patients achieving blood pressure ≤ 140 and/or 90 mmHg

  from baseline to week 8

• Ratio of responder patients (reduction of SBP ≥20 mmHg and/or DBP ≥10 mmHg)

  from baseline to week 8

• Absolute change of heart rate

  from baseline to week 8

• Correlation between absolute change in blood pressure and absolute change in heart rate

  from baseline to week 8

Study Arms (1)

Hypertensive patients

Hypertensive patients with elevated heart rate and type 2 diabetes mellitus

Eligibility Criteria

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

Study Population

State Hospital

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott: lead
• MonitorCRO: collaborator

Study Sites (23)

Research facility ID ORG-001108

Adana, 01330, Turkey (Türkiye)

Location

Research facility ID ORG-001030

Ankara, 06230, Turkey (Türkiye)

Location

Yıldırım Beyazıt University Yenimahalle Training and Research Hospital

Ankara, 6170, Turkey (Türkiye)

Location

Research facility ID ORG-001111

Antalya, 07059, Turkey (Türkiye)

Location

Research facility ID ORG-001120

Aydin, 09020, Turkey (Türkiye)

Location

Research facility ID ORG-001119

Aydin, 09100, Turkey (Türkiye)

Location

Research facility ID ORG-001116

Balıkesir, 10000, Turkey (Türkiye)

Location

Research facility ID ORG-001112

Burdur, 15300, Turkey (Türkiye)

Location

Research facility ID ORG-001123

Çorum, 19200, Turkey (Türkiye)

Location

Erzurum Regional Training and Research Hospital

Erzurum, 25040, Turkey (Türkiye)

Location

Atatürk University Aziziye Research Hospital

Erzurum, 25080, Turkey (Türkiye)

Location

Research facility ID ORG-001118

Istanbul, 34098, Turkey (Türkiye)

Location

Bakırköy Dr. Sadi Konuk Training and Research Hospital

Istanbul, 34147, Turkey (Türkiye)

Location

Research facility ID ORG-001117

Istanbul, 34303, Turkey (Türkiye)

Location

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

Istanbul, 34668, Turkey (Türkiye)

Location

Research facility ID ORG-001125

Istanbul, 34920, Turkey (Türkiye)

Location

Research facility ID ORG-001113

Karabük, 78100, Turkey (Türkiye)

Location

Research facility ID ORG-001110

Konya, 42250, Turkey (Türkiye)

Location

Research facility ID ORG-001115

Kırıkkale, 71400, Turkey (Türkiye)

Location

Research facility ID ORG-001122

Trabzon, 61800, Turkey (Türkiye)

Location

Uskudar PublicHospital

Üsküdar, 34662, Turkey (Türkiye)

Location

Yalova Public Hospital

Yalova, 77000, Turkey (Türkiye)

Location

Research facility ID ORG-001124

Zonguldak, 67900, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 32964020 DERIVED

MeSH Terms

Conditions

Hypertension; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Enver Atalar, Prof. Dr.

  Hacettepe University Faculty of Medicine Hospital Cardiology Clinic

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 20, 2014
• First Posted: November 24, 2014
• Study Start: October 1, 2014
• Primary Completion: December 31, 2015
• Study Completion: March 8, 2016
• Last Updated: March 27, 2018

Record last verified: 2018-03

Locations

TU (23)