TElmisartan and AMlodipine Single Pill sTudy With Patients Not on Goal With Mono rAas Therapy-switch

A Prospective, Open-label TElmisartan/AMlodipine Single Pill STudy to Assess the Efficacy in Patients With Essential Hypertension"..."

The general aim of this trial to determine the efficacy as measured by the percentage of patients reaching blood pressure goal at the end of the treatment period at 12 weeks. In-clinic blood pressures, home blood pressures and safety will be carefully monitored.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: telmisartan/amlodipine

Detailed Description

Study Design:

• Study Type: Interventional
• Enrollment (Actual): 502
• Phase: Phase 3

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany
    • 1235.33.49010 Boehringer Ingelheim Investigational Site
  • Frankfurt, Germany
    • 1235.33.49002 Boehringer Ingelheim Investigational Site
  • Haag, Germany
    • 1235.33.49007 Boehringer Ingelheim Investigational Site
  • Heidelberg, Germany
    • 1235.33.49003 Boehringer Ingelheim Investigational Site
  • Künzing, Germany
    • 1235.33.49005 Boehringer Ingelheim Investigational Site
  • Nürnberg, Germany
    • 1235.33.49008 Boehringer Ingelheim Investigational Site
  • Rednitzhembach, Germany
    • 1235.33.49009 Boehringer Ingelheim Investigational Site
  • Rodgau-Dudenhofen, Germany
    • 1235.33.49006 Boehringer Ingelheim Investigational Site
  • Unterschneidheim, Germany
    • 1235.33.49004 Boehringer Ingelheim Investigational Site
  • Westerkappeln, Germany
    • 1235.33.49001 Boehringer Ingelheim Investigational Site
• Italy
  • Arezzo, Italy
    • 1235.33.39009 Boehringer Ingelheim Investigational Site
  • Bologna, Italy
    • 1235.33.39002 Boehringer Ingelheim Investigational Site
  • Ferrara, Italy
    • 1235.33.39004 Boehringer Ingelheim Investigational Site
  • L'Aquila, Italy
    • 1235.33.39006 Boehringer Ingelheim Investigational Site
  • Napoli, Italy
    • 1235.33.39007 Boehringer Ingelheim Investigational Site
  • Pisa, Italy
    • 1235.33.39001 Boehringer Ingelheim Investigational Site
  • Roma, Italy
    • 1235.33.39008 Boehringer Ingelheim Investigational Site
  • Stradella (PV), Italy
    • 1235.33.39005 Boehringer Ingelheim Investigational Site
• Mexico
  • Aguascalientes, Mexico
    • 1235.33.52004 Boehringer Ingelheim Investigational Site
  • Durango, Mexico
    • 1235.33.52002 Boehringer Ingelheim Investigational Site
  • Guadalajara, Mexico
    • 1235.33.52001 Boehringer Ingelheim Investigational Site
  • Guadalajara, Mexico
    • 1235.33.52003 Boehringer Ingelheim Investigational Site
  • Guadalajara, Mexico
    • 1235.33.52007 Boehringer Ingelheim Investigational Site
  • Mexico, Mexico
    • 1235.33.52006 Boehringer Ingelheim Investigational Site
  • Mexico, Mexico
    • 1235.33.52009 Boehringer Ingelheim Investigational Site
  • Monterrey, Mexico
    • 1235.33.52008 Boehringer Ingelheim Investigational Site
• Netherlands
  • 's Hertogenbosch, Netherlands
    • 1235.33.31007 Boehringer Ingelheim Investigational Site
  • Almere, Netherlands
    • 1235.33.31009 Boehringer Ingelheim Investigational Site
  • Beek en Donk, Netherlands
    • 1235.33.31005 Boehringer Ingelheim Investigational Site
  • Beerzerveld, Netherlands
    • 1235.33.31002 Boehringer Ingelheim Investigational Site
  • Ermelo, Netherlands
    • 1235.33.31008 Boehringer Ingelheim Investigational Site
  • Lichtenvoorde, Netherlands
    • 1235.33.31006 Boehringer Ingelheim Investigational Site
  • Musselkanaal, Netherlands
    • 1235.33.31001 Boehringer Ingelheim Investigational Site
  • Nijverdal, Netherlands
    • 1235.33.31004 Boehringer Ingelheim Investigational Site
  • Wildervank, Netherlands
    • 1235.33.31003 Boehringer Ingelheim Investigational Site
• Poland
  • Chorzow, Poland
    • 1235.33.48005 Boehringer Ingelheim Investigational Site
  • Czestochowa, Poland
    • 1235.33.48002 Boehringer Ingelheim Investigational Site
  • Czestochowa, Poland
    • 1235.33.48003 Boehringer Ingelheim Investigational Site
  • Dabrowa Gornicza, Poland
    • 1235.33.48010 Boehringer Ingelheim Investigational Site
  • Grodzisk Mazowiecki, Poland
    • 1235.33.48006 Boehringer Ingelheim Investigational Site
  • Oswiecim, Poland
    • 1235.33.48013 Boehringer Ingelheim Investigational Site
  • Piotrkow Trybunalski, Poland
    • 1235.33.48008 Boehringer Ingelheim Investigational Site
  • Poznan, Poland
    • 1235.33.48004 Boehringer Ingelheim Investigational Site
  • Tychy, Poland
    • 1235.33.48001 Boehringer Ingelheim Investigational Site
  • Tychy, Poland
    • 1235.33.48009 Boehringer Ingelheim Investigational Site
  • Warszawa, Poland
    • 1235.33.48011 Boehringer Ingelheim Investigational Site
  • Wroclaw, Poland
    • 1235.33.48007 Boehringer Ingelheim Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria:

1. Ability to provide written informed consent in accordance with Good Clinical Practice and local legislation
2. Age 18 years or older
3. Patients with uncontrolled hypertension as defined SBP > 140 mmHg and SBP > 130 mmHg in patients with diabetes or renal impairment or DBP > 90 mmHg and DBP >80 mmHg in patients with diabetes or renal impairment after at least an 6 weeks of stable treatment with antihypertensive medication defined as treatment with the clinically recommended dose of a single RAAS blocking agent (Angiotensin Converting Enzym inhibition, AII Receptor Blocker and Direct Renin Inhibitor) at entering the trial. Renal impairment is defined as a creatinine >133µmol/l (1.5mg/dl) in male patients and a creatinine >124µmol/l (1.3mg/dl) in female patients or a creatinine clearance between 30-60 ml/min

Exclusion criteria:

1. Pre-menopausal women who are not surgically sterile; or are nursing or pregnant; or are not practising acceptable means of birth control or do not plan to continue using acceptable means of birth control throughout the study and do not agree to submit to pregnancy testing during participation in the trial. Acceptable methods of birth control include the transdermal patch, oral, implantable or injectable contraceptives, sexual abstinence and vasectomised partner.
2. Known or suspected secondary hypertension (e.g., renal artery stenosis or phaeochromocytoma).
3. Mean in-clinic seated cuff Systolic BP >180 mmHg and SBP >160 mmHg in patients with diabetes or renal impairment or Diastolic BP >110 mmHg and DBP >100 mmHg in patients with diabetes or renal impairment. Renal impairment is defined as a creatinine >133µmol/l (1.5mg/dl) in male patients and a creatinine >124µmol/l (1.3mg/dl) in female patients or a creatinine clearance between 30-60 ml/min.
4. Renal dysfunction as defined by the following laboratory parameters: Serum creatinine >3.0 mg/dl (or >265 ¿mol/L) and/or known creatinine clearance of <30 ml/min and/or clinical markers of severe renal impairment.
5. Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post-renal transplant patients or patients with only one kidney.
6. Clinically relevant hypokalaemia or hyperkalaemia (i.e., <3.5 or >5.5 mEq/L).
7. Uncorrected sodium or volume depletion.
8. Primary aldosteronism.
9. Hereditary fructose intolerance.
10. Congestive heart failure New York Heart Association functional class Congestive Heart Failure III-IV (Refer to Appendix 10.1).
11. Clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant cardiac arrhythmias as determined by the Investigator.
12. Biliary obstructive disorders (e.g., cholestasis) or hepatic insufficiency (defined as elevated levels of >2x bilirubin or >2x transaminases values). (Refer to Appendix 10.3)
13. Patients who have previously experienced symptoms characteristic of angioedema during treatment with ACE inhibitors or angiotensin-II receptor antagonists.
14. History of drug or alcohol dependency within six months prior to signing the informed consent form.
15. Any investigational drug therapy within one month of signing the informed consent.
16. Known hypersensitivity to any component of the trial drugs (telmisartan or amlodipine).
17. History of non-compliance or inability to comply with prescribed medications or protocol procedures.
18. Any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of the trial medication.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: telmisartan/amlodipine; start low dose and uptitrate to high dose on the basis of blood pressure goal	Drug: telmisartan/amlodipine; start low dose and uptitrate to high dose on the basis of BP goal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Patients Achieving Blood Pressure (BP) Control After 12 Weeks of Treatment Using In-clinic BP Measurements.	Achieving BP control is defined as SBP<140 mmHg and DBP<90 mmHg.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BP Control After 4 and 8 Weeks of Treatment Using In-clinic BP Measurements.	Achieving BP control is defined as SBP<140 mmHg and DBP<90 mmHg.	4 and 8 weeks
BP Control (Morning and Evening) After 12 Weeks of Treatment Using Home Blood Pressure Measurement (HBPM).	Achieving BP control with HBPM is defined as SBP<135 mmHg and DBP<85 mmHg.	Week 12
Change From Baseline Over Time in In-clinic Measured Mean SBP and Mean DBP		weeks 4, 8 and 12
Change From Baseline Over Time in In-clinic Measured Mean Pulse Rate	Pulse pressure was not analysed for this study instead pulse rate was analysed at weeks 4, 8 and 12.	weeks 4, 8 and 12
Change From Baseline Over Time in In-clinic Measured Mean Pulse Pressure		weeks 4, 8 and 12
DBP and SBP Control and Response Rates After 4, 8 and 12 Weeks of Treatment Using In-clinic BP Measurements	DBP control is defined as DBP <90 mmHg or <80 mmHg in patients with diabetes or renal impairment. SBP control is defined as SBP <140 mmHg or <130 mmHg in patients with diabetes or renal impairment. DBP response is defined as DBP <90 mmHg or <80 mmHg in patients with diabetes or renal impairment or a reduction from baseline >=10mmHg. SBP response is defined as SBP<140 mmHg or <130 mmHg in patients with diabetes or renal impairment or a reduction from baseline >=15mmHg.	weeks 4, 8 and 12
Percentage of Patients in Blood Pressure Categories Over Time	BP optimal: SBP <120 mmHg and DBP <80 mmHg, BP normal: SBP <130 mmHg and DBP <85 mmHg but not optimal, BP high-normal: SBP <140 mmHg and DBP <90 mmHg but not normal. Grade 1 hypertension: SBP <160 mmHg and DBP <100 mmHg but not high-normal, Grade 2 hypertension: SBP <180 mmHg and DBP <110 mmHg but not grade 1, Grade 3 hypertension: SBP >=180 mmHg or DBP >=110 mmHg.	weeks 4, 8 and 12
DBP and SBP Control and Response Rates Morning and Evening Over Time HBPM Measurements	DBP control: DBP <85 mmHg, SBP control: SBP <135 mmHg, DBP response: DBP <85 mmHg or a reduction from baseline >=10 mmHg, SBP response: SBP <135 mmHg or a reduction from baseline >= 15 mmHg	weeks 4, 8 and 12
Frequency of Patients Requiring Up-titration to Telmisartan 80mg Plus Amlodipine 10mg Combination (T80/A10) to Achieve Blood Pressure Control Over Time		weeks 4 and 8

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info
• Related Info

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: May 28, 2010
• First Submitted That Met QC Criteria: June 1, 2010
• First Posted (Estimate): June 2, 2010

Study Record Updates

• Last Update Posted (Estimate): January 15, 2014
• Last Update Submitted That Met QC Criteria: December 13, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Vasodilator Agents; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Amlodipine; Telmisartan; Telmisartan amlodipine combination
• Other Study ID Numbers: 1235.33; 2009-017336-40 (EudraCT Number: EudraCT)