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

NCT02242396 | Completed

• 1 other identifier: 502.496
• Study Type: observational
• Target: 5,248
• Locations: 0 countries
• Sites: N/A

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

Conditions

Hypertension

Outcome Measures

Primary Outcomes (2)

• Change of degree of Blood Pressure (BP) control in the early morning hours

  8 weeks of treatment

• Change from baseline in mSBP and mDBP by HBPM in the early morning

  BP control during the morning time-periods (6:00 to 11:59), BP \< 135/85 mmHg (HBPM: mean of morning measurements)

  Baseline, after 8 weeks of treatment

Secondary Outcomes (6)

• Change from baseline in office BP control rates

  Baseline, after 8 weeks

• Change from baseline in office BP response rates

  Baseline, after 8 weeks

• Reduction in mSBP and mDBP by OBPM

  Baseline, after 8 weeks

• Number of patients with adverse events

  up to 8 weeks

• Global Assessment of tolerability by investigator on a 6-point scale

  after 8 weeks

Study Arms (1)

Hypertensive patients

Drug: Telmisartan; Drug: Telmisartan hydrochlorothiazide

Interventions

Telmisartan DRUG

Also known as: Micardis®

Hypertensive patients

Telmisartan hydrochlorothiazide DRUG

Also known as: Micardis Plus®

Hypertensive patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hypertensive population under real life clinical practice in an ambulatory setting

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Hypertension

Interventions

Telmisartan; telmisartan, hydrochlorothiazide drug combination

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2014
• First Posted: September 17, 2014
• Study Start: August 1, 2005
• Primary Completion: November 1, 2007
• Last Updated: September 17, 2014

Record last verified: 2014-09