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

Completed

• Conditions: Hypertension

• Registration Number: NCT02298556
• Lead Sponsor: Abbott

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-11-20
• Study First Submitted QC: 2014-11-20
• Study First Posted: 2014-11-24
• Primary Completion: 2015-12-31
• Study Completion: 2016-03-08
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-26
• Last Update Posted: 2018-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 270

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Absolute change in systolic blood pressure	from baseline to week 8	mmHg

Secondary Outcome Measures

Name	Time	Method
Absolute change of heart rate	from baseline to week 8	beat/min
Absolute change in diastolic blood pressure (DBP)	from baseline to week 8	mmHg
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
Correlation between absolute change in blood pressure and absolute change in heart rate	from baseline to week 8
The absolute change in PR interval on electrocardiography	from baseline to week 8	ms. The PR interval indicates "atrioventricular conduction time".
The absolute change in HbA1c (if available)	from baseline to week 8
The absolute change in microalbuminuria (if available)	from baseline to week 8	mg/mmol
The ratio of patients experiencing an adverse event including the nature of the adverse event/severe adverse event	from baseline to week 8
The correlation between physician's office and home blood pressure measurements (Difference in medians)	from baseline to week 8	mmHg
Blood pressure variability (daily or hourly) in home blood pressure measurement	from baseline to week 8

Trial Locations

Locations (23)

Research facility ID ORG-001030; 🇹🇷 Ankara, Turkey

Research facility ID ORG-001111; 🇹🇷 Antalya, Turkey

Research facility ID ORG-001108; 🇹🇷 Adana, Turkey

Yıldırım Beyazıt University Yenimahalle Training and Research Hospital; 🇹🇷 Ankara, Turkey

Research facility ID ORG-001112; 🇹🇷 Burdur, Turkey

Research facility ID ORG-001116; 🇹🇷 Balıkesir, Turkey

Erzurum Regional Training and Research Hospital; 🇹🇷 Erzurum, Turkey

Atatürk University Aziziye Research Hospital; 🇹🇷 Erzurum, Turkey

Research facility ID ORG-001117; 🇹🇷 İstanbul, Turkey

Bakırköy Dr. Sadi Konuk Training and Research Hospital; 🇹🇷 Istanbul, Turkey

Research facility ID ORG-001124; 🇹🇷 Zonguldak, Turkey

Research facility ID ORG-001120; 🇹🇷 Aydın, Turkey

Research facility ID ORG-001110; 🇹🇷 Konya, Turkey

Uskudar PublicHospital; 🇹🇷 Uskudar, Turkey

Yalova Public Hospital; 🇹🇷 Yalova, Turkey

Dr. Siyami Ersek Göğüs Kalp ve Damar Cerrahisi Training and Research Hospital; 🇹🇷 Istanbul, Turkey

Research facility ID ORG-001119; 🇹🇷 Aydın, Turkey

Research facility ID ORG-001123; 🇹🇷 Çorum, Turkey

Research facility ID ORG-001118; 🇹🇷 İstanbul, Turkey

Research facility ID ORG-001125; 🇹🇷 İstanbul, Turkey

Research facility ID ORG-001115; 🇹🇷 Kırıkkale, Turkey

Research facility ID ORG-001122; 🇹🇷 Trabzon, Turkey

Research facility ID ORG-001113; 🇹🇷 Karabük, Turkey