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Telmisartan and Amlodipine Fixed Dose Combination Trial for the Treatment of Severe Hypertension
This study is currently recruiting participants.
Verified by Boehringer Ingelheim Pharmaceuticals, April 2009
First Received: March 11, 2009   Last Updated: April 23, 2009   History of Changes
Sponsored by: Boehringer Ingelheim Pharmaceuticals
Information provided by: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00860262
  Purpose

The primary objective of this trial is to demonstrate that following eight weeks of treatment the FDC of telmisartan 80 mg plus amlodipine 10 mg (T80/A10) is superior as first line therapy in reducing mean seated trough cuff SBP compared to the monotherapies of telmisartan 80 mg (T80) and amlodipine 10 mg (A10) in patients with severe hypertension. A key secondary objective is to identify the duration of treatment required to demonstrate the superiority of the FDC over both of the monotherapies.


Condition Intervention Phase
Hypertension
Drug: telmisartan
Drug: amlodipine
Phase IV

MedlinePlus related topics: High Blood Pressure
Drug Information available for: Amlodipine Amlodipine besylate Telmisartan
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Parallel Assignment, Safety/Efficacy Study
Official Title: An 8-Week Randomised, Double-Blind Study to Compare the Fixed-Dose Combination of Telmisartan 80 + Amlodipine 10mg Versus Amlodipine 10 mg Monotherapy as First Line Therapy in Patients With Severe Hypertension (Grade 3).

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • The primary endpoint for this trial is the change from baseline in the mean seated trough cuff SBP following eight weeks of treatment. [ Time Frame: 8 weeks ]

Secondary Outcome Measures:
  • Key secondary endpoints for this trial are the change from baseline in the mean seated trough cuff SBP following four and six weeks of treatment (T80/A10 versus T80 and A10) and following one and two weeks of treatment (T80/A5 versus T80 and A5). [ Time Frame: 8 weeks ]

Estimated Enrollment: 760
Study Start Date: March 2009
Estimated Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 severe hypertension as defined SBP greater than 180 mmHg and DBP greater than 95 mmHg at randomisation
  4. Ability to stop any current antihypertensive therapy without unacceptable risk to the patient (Investigators discretion)

Exclusion Criteria:

  1. Pre-menopausal women (last menstruation 1 year prior to signing informed consent) who:

    1. are not surgically sterile; or
    2. are nursing, or
    3. are pregnant, or
    4. are of childbearing potential and are NOT practicing acceptable methods of birth control, or do NOT plan to continue practicing an acceptable method throughout the trial.

    The only acceptable methods of birth control are:

    Intra Uterine Device (IUD) Oral Implantable or injectable contraceptives Estrogen patch Hormonal birth control should have been in use for at least three months before the study and continue at least until the next menstrual period after completing the study.

  2. Night shift workers who routinely sleep during the daytime and whose work hours include midnight to 4:00 a.m.
  3. Known or suspected secondary hypertension (e.g., renal artery stenosis or phaeochromocytoma)
  4. Mean in-clinic seated cuff SBP 200 mmHg and/or DBP 120 mmHg
  5. 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

  6. Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post-renal transplant patients or patients with only one kidney
  7. Clinically relevant hypokalemia or hyperkalemia (i.e., <3.5 or >5.5 mEq/L, may be rechecked for suspected error in result)
  8. Uncorrected sodium or volume depletion
  9. Primary aldosteronism
  10. Hereditary fructose intolerance
  11. Biliary obstructive disorders (e.g., cholestasis) or hepatic insufficiency
  12. Congestive heart failure NYHA functional class CHF III-IV (Refer to Appendix 10.3)
  13. Contra-indication to a placebo run-in period (e.g., stroke with-in the past six months, myocardial infarction, cardiac surgery, percutaneous transluminal coronary angioplasty, unstable angina or coronary artery bypass graft within the past three months prior to start of run-in period)
  14. Clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant cardiac arrhythmias as determined by the Investigator
  15. Hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, hemodynamically relevant stenosis of the aortic or mitral valve
  16. Patients whose diabetes has not been stable and controlled for at least the past three months as defined by an HbA1C 10%
  17. Patients who have previously experienced symptoms characteristic of angioedema during treatment with ACE inhibitors or angiotensin-II receptor antagonists
  18. History of drug or alcohol dependency within six months prior to signing the informed consent form
  19. Concomitant administration of any medications known to affect BP, except medications allowed by the protocol
  20. Any investigational drug therapy within one month of signing the informed consent
  21. Known hypersensitivity to any component of the trial drugs (telmisartan, amlodipine, or placebo)
  22. History of non-compliance or inability to comply with prescribed medications or protocol procedures
  23. 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00860262

Contacts
Contact: Boehringer Ingelheim Study Coordinator 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

  Show 164 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair )
Study ID Numbers: 1235.20, 2008-000873-40
Study First Received: March 11, 2009
Last Updated: April 23, 2009
ClinicalTrials.gov Identifier: NCT00860262     History of Changes
Health Authority: Bulgaria: Bulgarian Drug Agency, BG-1504 Sofia;   Czech Republic: State Institute for Drug Control (SUKL), CZ-100 41 Prague 10;   France: AFFSAPS;   Hungary: National Institute of Pharmacy, H-1051 Budapest;   Korea, Republic of: Korea Food and Drug Administration (KFDA);   Romania: National Medicines Agency, Bucharest;   Russia: Ministry of Healthcare and Social Development of Russian Federation, Moscow;   Slovakia: SUKL (state institute for drug control), SK-825 08 Bratislava 26;   Spain: Agencia Española del medicamento y Productos Sanitarios (AEMPS) Subdirección General de Medicamentos de uso humano Parque empresarial las Mercedes, edificio 8 C/ Campezo, 1 28022 Madrid / SPAIN;   Ukraine: Ministry of Health Care of Ukraine (MoH of Ukraine);   United States: Food and Drug Administration

Study placed in the following topic categories:
Vasodilator Agents
Vascular Diseases
Calcium Channel Blockers
Cardiovascular Agents
Antihypertensive Agents
Angiotensin II
Amlodipine
Protease Inhibitors
Angiotensin II Type 1 Receptor Blockers
Calcium, Dietary
Angiotensin-Converting Enzyme Inhibitors
Telmisartan
Hypertension

Additional relevant MeSH terms:
Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Vascular Diseases
Calcium Channel Blockers
Enzyme Inhibitors
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Protease Inhibitors
Amlodipine
Angiotensin II Type 1 Receptor Blockers
Membrane Transport Modulators
Therapeutic Uses
Angiotensin-Converting Enzyme Inhibitors
Cardiovascular Diseases
Telmisartan
Hypertension

ClinicalTrials.gov processed this record on May 07, 2009