Project name

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of XXXX in Subjects with Type 2 Diabetes with Inadequately Controlled Hypertension on an Angiotensin-Converting Enzyme Inhibitor (ACEI) or Angiotensin Receptor Blocker (ARB)

Institutions involved

Aggarwal and Associates Ltd., Recherches Cliniques Theradev, Manna Research, The Medical Arts Health Research Group, Recherche GCP Research, Dr. A. Nayar Medical Prof. Corp., Victoria Clinical Research Inc.

Investigators involved

Naresh Aggarwal, Didier Fay, Ben Lasko, Tersia Lichtenstein, Giuseppe Mazza, Arun Nayar, Lucretia van den Berg

City

Brampton, Granby, Toronto, Kelowna, Montreal, Saskatoon, Victoria

Province

ON, QC, SK, BC

Funding source

Pharmaceutical Sponsor

Project start date

Ongoing

Project end date

March 2013

Inclusion criteria

  • Males and females, 18 to 89 years old, with type 2 diabetes with inadequate glycemic control HbA1c between 7-10.5% and uncontrolled hypertension Systolic Blood Pressure (SBP) 140-165 and Diastolic Blood Pressure (DBP) 85-105
  • Stable dose of oral antidiabetic agent (OAD) for at least 6 weeks [12 wks for Thiazolidinedione (TZD)] or a stable daily dose of insulin, as a monotherapy or in combination with another OAD, for 8 weeks, and a stable dose of ACEI or ARB for at least 4 weeks
  • C-peptide ≥ 0.8 ng/mL
  • Body Mass Index ≤ 45.0 kg/m2
  • Serum creatinine < 1.50 mg/dL for men or < 1.40 mg/dL for women

Brief abstract of project and relevance

Study Type: Interventional

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)

Primary purpose

Treatment

Primary outcome measures

  • Change from baseline in seated systolic blood pressure after 12 weeks of treatment
  • Change from baseline in Glycosylated hemoglobin (HbA1c) after 12 weeks of treatment

Secondary outcome measures

  • Change from baseline in 24-hr ambulatory systolic blood pressure after 12 weeks of treatment
  • Change in 24-hr ambulatory diastolic blood pressure after 12 weeks of treatment
  • Change in serum uric acid after 12 weeks of treatment

Ethical approval

Yes

Rationale for posting

for recruitment

Contact information

If you wish to find out more information about our trial, or if you are interested in participating, please contact the person at the location that is most convenient for yo

Investigator Name: Aggarwal, Naresh
Contact Name:
Paula Borg
Aggarwal and Associates Ltd.
490 Bramalea Road 201
Brampton, ON L6T 0G1
905-458-9033
paula.borg@yahoo.ca

Investigator Name: Fay, Didier
Contact Name:
Claudette Robert
Recherches Cliniques Theradev
4 Robinson Road
Granby, QC J2G 8Z9
450-378-8805
robert@theradev.ca

Investigator Name: Lasko, Ben
Manna Research 2291 Kipling Avenue; Unit 117B
Toronto, ON M9W 4L6
416-740-2895
joan.thompson@mannaresearch.com

Investigator Name: Lichtenstein, Tersia
Contact Name:
Florence Hunter
The Medical Arts Health Research Group
1605 Gordon Drive
Kelowna, BC V1Y 3G8
250-763-1791
flo@healthresearch.ca

Investigator Name: Mazza, Giuseppe
Contact Name:
Dr. Giuseppe Mazza
Recherche GCP Research
1021 Jean Talon East; Suite 200
Montreal, QC H2R 1V6
514-787-1818
mazza.pi@recherchegcp.com

Investigator Name: Nayar, Arun
Contact Name:
Geeta Nayar
Dr. A. Nayar Medical Prof. Corp.
125-750 Spadina Cres. E
Saskatoon, SK S7K 3H3
306-652-5414
nayar@sasktel.net

Investigator Name: van den Berg, Lucretia
Contact Name:
Veronica Anthony
Victoria Clinical Research Inc.
109-1026 Johnson Street
Victoria, BC V8V 3N7
250-213-5011
veronica@vcrinc.ca