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CompletedNCT02242864Updated Sep 17, 2014

Study to Evaluate the Effect of the Treatment With Micardis® or MicardisPlus® on Blood Pressure

An observational study in Hypertension, sponsored by Boehringer Ingelheim. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-09-17.

Sponsored by Boehringer Ingelheim · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,527
Ages
18 Years and older
Sex
All
01

Study summary

The primary objective was to evaluate the effect of the treatment with Micardis® or MicardisPlus® on blood pressure. Secondary objectives were the effect of Micardis® / MicardisPlus® on metabolic parameters (triglycerides, cholesterol, LDL blood glucose, insulin Homeostasis Model Assessment (HOMA)-index and HbA1c) in patients with essential hypertension and diabetes mellitus

02

Conditions studied

  • Hypertension

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03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 1,527 is above the median of 210 across 1,359 observational studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Outpatients with hypertension and diabetes mellitus

Inclusion criteria

  • Age > 18 years
  • Hypertension
  • Diabetes mellitus

Exclusion criteria

Exclusion Criteria:

  • Age \< 18 years
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,527 participants (actual)
Patient registry
No

Groups and cohorts

  • Patients with hypertension and diabetes mellitus

    Drug: Micardis® · Drug: MicardisPlus®

Interventions

  • DrugMicardis®
  • DrugMicardisPlus®
06

What researchers measure

Primary outcomes

  1. Change from Baseline in systolic blood pressure (SBP)

    Time frame: Baseline, after 6 months

  2. Change from Baseline in diastolic blood pressure (DBP)

    Time frame: Baseline, after 6 months

Secondary outcomes

  1. Assessment of efficacy by investigator on a 6-point scale

    Time frame: after 6 months

  2. Assessment of metabolic effect on a 3-point scale

    Time frame: after 6 months

  3. Change from Baseline in laboratory parameters

    Metabolic parameters - Triglyceride, total cholesterol, blood glucose, insulin, HOMA-Index, HbA1c

    Time frame: Baseline, after 6 months

  4. Assessment of tolerability by investigator on a 5-point scale

    Time frame: after 6 months

  5. Number of patients with adverse events

    Time frame: up to 6 months

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 17, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02242864
Lead sponsor
Boehringer Ingelheim
Responsible party
Sponsor
First posted
Sep 17, 2014
Start date
Jan 2006
Primary completion
Oct 2006
Last update
Sep 17, 2014
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.

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