NCT02242864

Brief 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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,527

participants targeted

Target at P75+ for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2006

Completed
8 years until next milestone

First Submitted

Initial submission to the registry

September 16, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 17, 2014

Completed
Last Updated

September 17, 2014

Status Verified

September 1, 2014

Enrollment Period

9 months

First QC Date

September 16, 2014

Last Update Submit

September 16, 2014

Conditions

Hypertension

Outcome Measures

Primary Outcomes (2)

  • Change from Baseline in systolic blood pressure (SBP)

    Baseline, after 6 months

  • Change from Baseline in diastolic blood pressure (DBP)

    Baseline, after 6 months

Secondary Outcomes (5)

  • Assessment of efficacy by investigator on a 6-point scale

    after 6 months

  • Assessment of metabolic effect on a 3-point scale

    after 6 months

  • Change from Baseline in laboratory parameters

    Baseline, after 6 months

  • Assessment of tolerability by investigator on a 5-point scale

    after 6 months

  • Number of patients with adverse events

    up to 6 months

Study Arms (1)

Patients with hypertension and diabetes mellitus

Drug: Micardis®Drug: MicardisPlus®

Interventions

Micardis®DRUG
Patients with hypertension and diabetes mellitus
MicardisPlus®DRUG
Patients with hypertension and diabetes mellitus

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Outpatients with hypertension and diabetes mellitus

You may qualify if:

  • Age \> 18 years
  • Hypertension
  • Diabetes mellitus

You may not qualify if:

  • Age \< 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hypertension

Interventions

Telmisartantelmisartan, hydrochlorothiazide drug combination

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2014

First Posted

September 17, 2014

Study Start

January 1, 2006

Primary Completion

October 1, 2006

Last Updated

September 17, 2014

Record last verified: 2014-09