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Trial record 53 of 71 for:    TELMISARTAN AND HYDROCHLOROTHIAZIDE

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

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ClinicalTrials.gov Identifier: NCT02243566
Recruitment Status : Completed
First Posted : September 18, 2014
Last Update Posted : September 18, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
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

Condition or disease Intervention/treatment
Hypertension Drug: MicardisPlus®

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Study Type : Observational
Actual Enrollment : 2707 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Morning Hypertension and Patient Self-monitoring
Study Start Date : April 2006
Actual Primary Completion Date : January 2007

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Essential hypertension Drug: MicardisPlus®
Other Name: Telmisartan in combination with hydrochlorothiazide




Primary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Outpatients with essential hypertension
Criteria

Inclusion Criteria:

  • Age > 18 years
  • Hypertension

Exclusion Criteria:

  • Age < 18 years

Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02243566    
Other Study ID Numbers: 502.513
First Posted: September 18, 2014    Key Record Dates
Last Update Posted: September 18, 2014
Last Verified: September 2014
Additional relevant MeSH terms:
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Hydrochlorothiazide
Telmisartan, hydrochlorothiazide drug combination
Hypertension
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists