ICTRP Search Portal

Main

Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT02298556
Date of registration:	20/11/2014
Prospective Registration:	No
Primary sponsor:	Abbott
Public title:	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 HARVEST-TR
Scientific 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
Date of first enrolment:	October 2014
Target sample size:	270
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02298556
Study type:	Observational
Study design:
Phase:

Countries of recruitment
Turkey

Contacts

Name:	Enver Atalar, Prof. Dr.
Address:
Telephone:
Email:
Affiliation:	Hacettepe University Faculty of Medicine Hospital Cardiology Clinic

Key inclusion & exclusion criteria

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

Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Hypertension

Intervention(s)

Primary Outcome(s)

Absolute change in systolic blood pressure [Time Frame: from baseline to week 8]

Secondary Outcome(s)

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]

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]

Absolute change in diastolic blood pressure (DBP) [Time Frame: from baseline to week 8]

The absolute change in HbA1c (if available) [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]

Ratio of patients achieving blood pressure = 140 and/or 90 mmHg [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 absolute change in PR interval on electrocardiography [Time Frame: from baseline to week 8]

The absolute change in microalbuminuria (if available) [Time Frame: from baseline to week 8]

Secondary ID(s)

GSS-13-0019

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

MonitorCRO

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.