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Trial record 49 of 71 for:    TELMISARTAN AND HYDROCHLOROTHIAZIDE

Evaluation of Efficacy and Tolerability of Micardis® / MicardisPlus® Under Usual Daily-practice Prescribing in Patients With Hypertension

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ClinicalTrials.gov Identifier: NCT02242383
Recruitment Status : Completed
First Posted : September 17, 2014
Last Update Posted : September 17, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
To evaluate efficacy and tolerability of Micardis® / MicardisPlus® under usual daily-practice prescribing conditions with a special emphasis on controlling morning blood pressure

Condition or disease Intervention/treatment
Hypertension Drug: Telmisartan Drug: Telmisartan in combination with hydrochlorothiazide

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Study Type : Observational
Actual Enrollment : 13248 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Morning Hypertension and Monitoring of Metabolism (AWB Morgenhochdruck & Stoffwechselmonitoring)
Study Start Date : January 2005
Actual Primary Completion Date : October 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Telmisartan

Group/Cohort Intervention/treatment
Essential hypertension Drug: Telmisartan
Drug: Telmisartan in combination with hydrochlorothiazide



Primary Outcome Measures :
  1. Changes in morning blood pressure (BP) [ Time Frame: Pre-dose, up to 6 months after start of treatment ]
  2. Changes in metabolic laboratory parameters [ Time Frame: Pre-dose, up to 6 months after start of treatment ]
  3. Changes in morning blood pressure in patients with or without telemonitoring (TM) of BP [ Time Frame: Pre-dose, up to 6 months after start of treatment ]
  4. Investigator assessment of efficacy in reducing morning hypertension on a 5-point rating scale [ Time Frame: Up to 6 months after start of treatment ]
  5. Investigator assessment of effects on metabolism on a 3-point rating scale [ Time Frame: Up to 6 months after start of treatment ]
  6. Investigator assessment of tolerability on a 5-point rating scale [ Time Frame: Up to 6 months after start of treatment ]
  7. Number of patients with adverse events [ Time Frame: Up to 6 months ]
  8. Changes in morning heart rate [ Time Frame: Pre-dose, up to 6 months after start of treatment ]


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, insufficiently treated hypertension

Exclusion Criteria:

- Age < 18 years


Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02242383    
Other Study ID Numbers: 502.485
First Posted: September 17, 2014    Key Record Dates
Last Update Posted: September 17, 2014
Last Verified: September 2014
Additional relevant MeSH terms:
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Hydrochlorothiazide
Telmisartan
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