Direct Renin Inhibition Effects on Atherosclerotic Biomarkers

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Texas Tech University Health Sciences Center

ClinicalTrials.gov Identifier:

NCT00818779

First received: January 6, 2009

Last updated: October 18, 2012

Last verified: October 2012

History of Changes

Results First Received: June 18, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Pharmacodynamics Study; Intervention Model: Parallel Assignment; Masking: Open Label
Conditions:	Coronary Artery Disease Type 2 Diabetes Mellitus
Interventions:	Drug: Aliskiren Drug: Amlodipine

Participant Flow

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Aliskiren	Aliskiren 150-300 mg once daily
Amlodipine	5-10 mg amlodipine once daily

Participant Flow: Overall Study

	Aliskiren	Amlodipine
STARTED	22	16
COMPLETED	16	15
NOT COMPLETED	6	1
Protocol Violation	1	0
Lost to Follow-up	1	0
Adverse Event	4	1

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
Aliskiren	Aliskiren 150-300 mg once daily
Amlodipine	5-10 mg amlodipine once daily
Total	Total of all reporting groups

Baseline Measures

	Aliskiren	Amlodipine	Total
Number of Participants [units: participants]	22	16	38
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	7	6	13
>=65 years	15	10	25
Age [units: years] Mean ± Standard Deviation	68 ± 10	63 ± 16	65 ± 13
Gender [units: participants]
Female	8	6	14
Male	14	10	24
Region of Enrollment [units: participants]
United States	22	16	38

Outcome Measures

1. Primary:

Plasminogen Activator Inhibitor 1 [ Time Frame: 6 weeks ]

Show Outcome Measure 1

2. Secondary:

Serum Level of Vascular Cell Adhesion Molecule [ Time Frame: 6 week ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

3. Secondary:

Serum Level of Intracellular Cell Adhesion Molecule [ Time Frame: 6 week ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

4. Secondary:

Serum Level of C-reactive Protein [ Time Frame: 6 week ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

5. Secondary:

Serum Level of Nitric Oxide [ Time Frame: 6 week ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Small sample size led to large standard deviation in biomarkers assessed and limited power to detect a diffference

Results Point of Contact:

Name/Title: Gary Meyerrose
Organization: Texas Tech University Health Sciences Center School of Medicine
phone: 806-743-3150
e-mail: gary.meyerrose@ttuhsc.edu

No publications provided

Responsible Party:	Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier:	NCT00818779 History of Changes
Other Study ID Numbers:	Tekturna 1
Study First Received:	January 6, 2009
Results First Received:	June 18, 2012
Last Updated:	October 18, 2012
Health Authority:	United States: Institutional Review Board

To Top