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Completed

NCT Number: NCT02242396

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

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

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year–80 year

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

  • 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

Treatment and study plan

Telmisartan

Drug

Other names: Micardis®

Telmisartan hydrochlorothiazide

Drug

Other names: Micardis Plus®

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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)

Important dates

Study start
2005
Primary completion
2007
First posted
Sep 17, 2014
Registry last updated
Sep 17, 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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