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OpenTrials
Completed

NCT Number: NCT02243566

Post-marketing Surveillance Study With MicardisPlus® in Treatment of Morning Hypertension (Self-monitored by Patient)

The purpose of the study was to examine the effect of six- to eight-week treatment with MicardisPlus® on blood pressure and the effect of patient self-monitoring on blood pressure control. In addition, the post-marketing surveillance study offered the possibility to obtain information about the influence on different laboratory parameters during treatment with MicardisPlus® from an unselected patient group under office conditions

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age > 18 years
  • Hypertension

Exclusion criteria

  • Age < 18 years

Treatment and study plan

MicardisPlus®

Drug

Other names: Telmisartan in combination with hydrochlorothiazide

Primary outcomes

  1. Changes in morning blood pressure (systolic and diastolic)

    Time frame: Pre-dose, up to 8 weeks after start of treatment

  2. Changes from baseline in laboratory values

    Time frame: Pre-dose, up to 8 weeks after start of treatment

  3. Investigator assessment of efficacy on a 5-point scale

    Time frame: Up to 8 weeks after start of treatment

  4. Investigator assessment of influence on metabolism on a 3-point scale

    Time frame: Up to 8 weeks after start of treatment

  5. Investigator assessment of tolerability on a 5-point scale

    Time frame: Up to 8 weeks after start of treatment

  6. Number of patients with adverse events

    Time frame: Up to 8 weeks

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Morning Hypertension and Patient Self-monitoring

Important dates

Study start
2006
Primary completion
2007
First posted
Sep 18, 2014
Registry last updated
Sep 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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