Last updated on August 2012

Clinical Trial to evaluate the safety and efficacy of a new medication in patients with Type II Diabetes with Inadequately Controlled Hypertension.


Brief description of study

Clinical Trial to evaluate the safety and efficacy of a new medication in patients with Type II Diabetes with Inadequately Controlled Hypertension.

Detailed Study Description

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

Patient Inclusion Criteria:

  • Subjects must be willing and able to give signed and dated written informed consent.
  • Subjects must have type 2 diabetes with inadequate glycemic control obtained at the enrollment visit.
  • Subjects must have inadequately controlled hypertension
  • Men and women ages must be ≥ 18 and ≤ 89 years old at the time of the enrollment visit. Men and women of childbearing potential (WOCBP) must be using an acceptable method of contraception to avoid pregnancy throughout the study in such a manner that the risk of pregnancy is minimized.
  • Women must not be breastfeeding

Patient Exclusion Criteria:

  • History of diabetes insipidus.
  • History of malignant or accelerated hypertension.
  • Subject is currently abusing alcohol or other drugs or has done so within the last 6 months.

Additional protocol-defined inclusion/exclusion criteria may apply, please contact us for more information.

Clinical Study Identifier: TX136179

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Luis Estevez

IMA Research
Miami, FL USA
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