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Trial record 36 of 71 for:    TELMISARTAN AND HYDROCHLOROTHIAZIDE

A Study of a Hypertensive Population Under Treatment With Micardis® and Micardis Plus® to Control the Early Morning BP Rise (SURGE II)

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ClinicalTrials.gov Identifier: NCT02242396
Recruitment Status : Completed
First Posted : September 17, 2014
Last Update Posted : September 17, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:

The primary objective was to evaluate, through the use of Home blood pressure monitoring (HBPM), the degree of BP control in the early morning hours after 8 weeks of treatment in patients with essential hypertension under treatment with Micardis®, Telmisartan or Micardis Plus®, Telmisartan hydrochlorothiazide.

The co-primary endpoints were the degree of BP control, and change from baseline until study end in mean systolic blood pressure (mSBP) and mean diastolic blood pressure (mDBP) HBPM in the early morning hours after 8 weeks of treatment with Micardis®, Telmisartan or Micardis Plus®, Telmisartan hydrochlorothiazide.

Secondary endpoints were office BP control rates, office BP response rates, and reduction in mSBP and mDBP Office blood pressure measurement (OBPM) from baseline to final visit, discontinuations and tolerability


Condition or disease Intervention/treatment
Hypertension Drug: Telmisartan Drug: Telmisartan hydrochlorothiazide

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Study Type : Observational
Actual Enrollment : 5248 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Study of a Hypertensive Population Under Treatment With Micardis® and Micardis Plus® Under Real Clinical Conditions With the Goal to Control the Early Morning BP Rise (SURGE II)
Study Start Date : August 2005
Actual Primary Completion Date : November 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Telmisartan

Group/Cohort Intervention/treatment
Hypertensive patients Drug: Telmisartan
Other Name: Micardis®

Drug: Telmisartan hydrochlorothiazide
Other Name: Micardis Plus®




Primary Outcome Measures :
  1. Change of degree of Blood Pressure (BP) control in the early morning hours [ Time Frame: 8 weeks of treatment ]
  2. Change from baseline in mSBP and mDBP by HBPM in the early morning [ Time Frame: Baseline, after 8 weeks of treatment ]
    BP control during the morning time-periods (6:00 to 11:59), BP < 135/85 mmHg (HBPM: mean of morning measurements)


Secondary Outcome Measures :
  1. Change from baseline in office BP control rates [ Time Frame: Baseline, after 8 weeks ]
  2. Change from baseline in office BP response rates [ Time Frame: Baseline, after 8 weeks ]
  3. Reduction in mSBP and mDBP by OBPM [ Time Frame: Baseline, after 8 weeks ]
  4. Number of patients with adverse events [ Time Frame: up to 8 weeks ]
  5. Global Assessment of tolerability by investigator on a 6-point scale [ Time Frame: after 8 weeks ]
  6. Global assessment efficacy by investigator on 6-point scale [ Time Frame: after 8 weeks ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hypertensive population under real life clinical practice in an ambulatory setting
Criteria

Inclusion Criteria:

  • Patients male or female between 18 and 80 years of age
  • Patients with mild to moderate essential hypertension
  • Patients diagnosed with hypertension that are not currently taking antihypertensive medication or previously diagnosed hypertensive patients who are uncontrolled with their current treatment

Exclusion Criteria:

  • Pre-menopausal women who have no birth control, who are pregnant or nursing
  • Patients with advanced hepatic impairment or advanced renal impairment
  • Patients with New York Heart Association (NYHA) functional class III or IV congestive heart failure (CHF), unstable angina, acute myocardial infarction, heart surgery or stroke within the previous six months
  • Patients with any type of relevant arrhythmia according to the assessment of the investigator
  • Patients with any valvular disease with hemodynamic repercussion
  • Patients receiving chronic administration of oral anticoagulants or digoxin
  • Patients with known hypersensitivity to any component in the formulation of Micardis®, Telmisartan or Micardis Plus®, Telmisartan hydrochlorothiazide
  • Patients with previous history of angioedema associated with angiotensin converting enzyme (ACE) inhibitors
  • Patients with severe, uncontrolled hypertension or any form of secondary hypertension
  • Patients with any other clinical conditions which, in the opinion of the investigator, would not allow for the safe completion of the protocol

Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02242396     History of Changes
Other Study ID Numbers: 502.496
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
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