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

  • STATUS
    Recruiting
Updated on 8 November 2020

Summary

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

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.

Details
Condition Diabetes Mellitus, Type 2, High Blood Pressure (Hypertension)
Clinical Study IdentifierTX136179
Last Modified on8 November 2020

Eligibility

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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