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Study to Evaluate the Effect of Micardis® / MicardisPlus® on Metabolic Parameters in Patients With Essential Hypertension and Diabetes Mellitus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02242825
Recruitment Status : Completed
First Posted : September 17, 2014
Last Update Posted : September 17, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Tracking Information
First Submitted Date September 16, 2014
First Posted Date September 17, 2014
Last Update Posted Date September 17, 2014
Study Start Date January 2006
Actual Primary Completion Date October 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 16, 2014)
  • Change from Baseline in systolic blood pressure (SBP) [ Time Frame: Baseline, after 6 months ]
  • Change from Baseline in diastolic blood pressure (DBP) [ Time Frame: Baseline, afterr 6 months ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: September 16, 2014)
  • Assessment of efficacy by investigator on a 6-point scale [ Time Frame: after 6 months ]
  • Assessment of metabolic effect on a 4-point scale [ Time Frame: after 6 months ]
  • Change from Baseline in laboratory parameters [ Time Frame: Baseline, after 6 months ]
    Metabolic parameters - Triglyceride, total cholesterol, blood glucose and HbA1c
  • Assessment of tolerability by investigator on a 5-point scale [ Time Frame: after 6 months ]
  • Number of patients with adverse events [ Time Frame: up to 6 months ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Study to Evaluate the Effect of Micardis® / MicardisPlus® on Metabolic Parameters in Patients With Essential Hypertension and Diabetes Mellitus
Official Title Micardis® / MicardisPlus® Monitoring of Morning Hypertension and Metabolism II
Brief Summary The primary objective is to evaluate the effect of the treatment with Micardis® or MicardisPlus® on blood pressure. Secondary objectives are the effect of Micardis® / MicardisPlus® on metabolic parameters (triglycerides, cholesterol, blood glucose and HbA1c) in patients with essential hypertension and diabetes mellitus
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with hypertension and diabetes mellitus recruited by cardiologists, nephrologists or diabetologists
Condition Hypertension
Intervention
  • Drug: Micardis®
  • Drug: MicardisPlus®
Study Groups/Cohorts Patients with hypertension and diabetes mellitus
Interventions:
  • Drug: Micardis®
  • Drug: MicardisPlus®
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 16, 2014)
8148
Original Actual Enrollment Same as current
Study Completion Date Not Provided
Actual Primary Completion Date October 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Age > 18 years
  • Hypertension
  • Diabetes mellitus

Exclusion Criteria:

  • Age < 18 years
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT02242825
Other Study ID Numbers 502.505
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Boehringer Ingelheim
Study Sponsor Boehringer Ingelheim
Collaborators Not Provided
Investigators Not Provided
PRS Account Boehringer Ingelheim
Verification Date September 2014