Using Telmisartan Alone or Combination of Telmisartan -HCTZ in the Treatment of Mild to Moderate Essential Hypertension


Tracking Information

Start Date  ICMJESeptember 2004
Estimated Primary Completion DateOctober 2009   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 15, 2009)		Primary Endpoints will be the change from baseline in mean systolic blood pressure [ Time Frame: 4-24 Weeks ]
Original Primary Outcome Measures ICMJE 
 (submitted: March 18, 2008)		Primary Endpoints will be the change from baseline in mean systolic blood pressure [ Time Frame: 4-24 Weeks ]
Change HistoryComplete list of historical versions of study NCT00638911 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE 
 (submitted: May 15, 2009)		Secondary Endpoints are clinical control of the BP and response rate. Other secondary Endpoints will be discontinuations and tolerability. [ Time Frame: 4-24 Weeks ]
Original Secondary Outcome Measures ICMJE 
 (submitted: March 18, 2008)		Secondary Endpoints are clinical control of the BP and response rate. Other secondary Endpoints will be discontinuations and tolerability. [ Time Frame: 4-24 Weeks ]

Descriptive Information

Brief Title  ICMJEUsing Telmisartan Alone or Combination of Telmisartan -HCTZ in the Treatment of Mild to Moderate Essential Hypertension
Official Title  ICMJEPMS Assessing the Safety and Efficacy of Telmisartan in Patients With Mild-to-moderate Essential Hypertension
Brief Summary

The aim of this therapeutic observation is to demonstrate the efficacy and safety of telmisartan or telmisartan and HCTZ in the treatment of patients with mild-to-moderate essential hypertension under normal conditions of use after market launch.

Detailed Description

Study Design: Non-interventional, post marketing study

Study Phase 
Study Type  ICMJEObservational
Study Design  ICMJEOther, Prospective
Condition  ICMJEHypertension
Intervention  ICMJE
  • Drug: telmisartan
  • Drug: telmisartan + hydrochlorothiazide

Recruitment Information

Estimated Enrollment  ICMJE9435
Completion Date 
Estimated Primary Completion DateOctober 2009   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

1.Male or female patients over the age of 18 years, with mild-to-moderate essential hypertension with values of mean morning seated diastolic BP more than 90 mmHg and less than 109 mmHg and or mean morning seated systolic BP more than 140 mmHg and less than 180 mmHg

  1. newly diagnosed patients
  2. patients failing to reach target blood pressure of less than 140 on 90 on their current antihypertensive treatment

Exclusion Criteria:

  1. Pre-menopausal women who do not use adequate contraception who are pregnant or nursing
  2. Cholestasis and biliary obstructive disorders
  3. Severe hepatic impairment
  4. Severe renal impairment creatinine clearance less than 30 ml pro min
  5. Refractory hypokalaemia hypercalcaemia
  6. Known hypersensitivity to any component in the formulation of Micardis/Micardis Plus
GenderBoth
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Boehringer Ingelheim Study Coordinator1-800-243-0127clintriage.rdg@boehringer-ingelheim.com
Location Countries  ICMJEHungary,   Poland,   Romania,   Russian Federation,   Slovakia,   Slovenia

Administrative Information

NCT ID  ICMJENCT00638911
Responsible PartyBoehringer Ingelheim, Study Chair, Boehringer Ingelheim
Study ID Numbers  ICMJE502.465
Study Sponsor  ICMJEBoehringer Ingelheim Pharmaceuticals
Collaborators  ICMJE 
Investigators  ICMJE
Study Chair:Boehringer IngelheimBoehringer Ingelheim Pharmaceuticals
Information Provided ByBoehringer Ingelheim Pharmaceuticals