Overview

This trial is active, not recruiting.

Condition hypertension
Sponsor Abbott
Collaborator Monitor Medikal Araştırma ve Danışmanlık Tic.Ltd.Şti (MonitorCRO)
Start date October 2014
End date March 2016
Trial size 270 participants
Trial identifier NCT02298556, GSS-13-0019

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Arm
Hypertensive patients with elevated heart rate and type 2 diabetes mellitus

Primary Outcomes

Measure
Absolute change in systolic blood pressure
time frame: from baseline to week 8

Secondary Outcomes

Measure
Absolute change in diastolic blood pressure (DBP)
time frame: from baseline to week 8
Ratio of patients achieving blood pressure ≤ 140 and/or 90 mmHg
time frame: from baseline to week 8
Ratio of responder patients (reduction of SBP ≥20 mmHg and/or DBP ≥10 mmHg)
time frame: from baseline to week 8
Absolute change of heart rate
time frame: from baseline to week 8
Correlation between absolute change in blood pressure and absolute change in heart rate
time frame: from baseline to week 8
The absolute change in PR interval on electrocardiography
time frame: from baseline to week 8
The absolute change in HbA1c (if available)
time frame: from baseline to week 8
The absolute change in microalbuminuria (if available)
time frame: from baseline to week 8
The ratio of patients experiencing an adverse event including the nature of the adverse event/severe adverse event
time frame: from baseline to week 8
The correlation between physician's office and home blood pressure measurements (Difference in medians)
time frame: from baseline to week 8
Blood pressure variability (daily or hourly) in home blood pressure measurement
time frame: from baseline to week 8

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Prospective Noninterventional, Observational Study to Describe the Effectiveness of Angiotensin Converting Enzyme Inhibitor and Non-dihydropyridine Calcium Channel Blocker Single Pill Combination in the Management of Hypertensive Patients With Elevated Heart Rate and Type 2 Diabetes Mellitus
Principal investigator Enver Atalar, Prof. Dr.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Abbott.