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Telmisartan/Amlodipine (80/5) vs. Telmisartan/Amlodipine (40/5) vs. Amlodipine 10 or 5 in Resistant Hypertension
This study has been completed.
Sponsored by: Boehringer Ingelheim Pharmaceuticals
Information provided by: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00558428
  Purpose

The primary objectives of this trial are (a) to demonstrate that the fixed-dose combination T40/A5 or the fixed-dose combination T80/A5 is superior in reducing blood pressure at eight weeks compared with A5 (b) to demonstrate that the fixed-dose combination T40/A5 or the fixed-dose combination T80/A5 is not inferior in reducing blood pressure at eight weeks compared with A10 and (c) to demonstrate that the incidence of oedema on the fixed-dose combination T40/A5 pooled with the fixed-dose combination T80/A5 is superior (less oedema) to A10 in patients who fail to respond adequately to six weeks treatment with A5.


Condition Intervention Phase
Hypertension
Drug: fixed dose combination of telmisartan+amlodipine
Drug: amlodipine
Phase III

MedlinePlus related topics: Edema High Blood Pressure
Drug Information available for: Telmisartan Amlodipine Amlodipine besylate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Parallel Assignment, Safety/Efficacy Study
Official Title: An Eight-Week Randomized, 4-Arm, Double-Blind Study to Compare the Efficacy and Safety of Combinations of Telmisartan 40mg + Amlodipine 5mg Versus Telmisartan 80mg + Amlodipine 5mg Versus Amlodipine 5mg Versus Amlodipine 10mg Monotherapy in Patients With Hypertension Who Fail to Respond Adequately to Treatment With Amlodipine 5mg Monotherapy

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • The co primary endpoints are the change from baseline in DBP and the rate of incidence of oedema adverse events. [ Time Frame: 8 weeks ]

Secondary Outcome Measures:
  • the change from baseline in seated SBP. the proportion of patients achieving DBP control [ Time Frame: 8 weeks ]

Enrollment: 1098
Study Start Date: October 2007
Primary Completion Date: September 2008 (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. patients aged at least 18 years at the date of signing the consent form
  2. diagnosis of essential hypertension and blood pressure not adequately controlled before enrolment in the study
  3. failure to respond adequately to six weeks treatment with amlodipine 5 mg monotherapy
  4. able to stop any current antihypertensive therapy without unacceptable risk to the patient (Investigator's decision)
  5. willing and able to provide written informed consent (in accordance with Good Clinical Practice and local legislation).

Exclusion Criteria:

  1. 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
  3. mean seated SBP over 200 mmHg and/or mean seated DBP over 120 mmHg at Visit 1 or 2 or mean seated SBP over 180 mmHg and/or mean seated DBP over 120 mmHg at the end of the run-in period (Visit 3)
  4. any clinically significant hepatic impairment (e.g. clinically significant cholestasis, biliary obstructive disorder or hepatic insufficiency)
  5. severe renal impairment (e.g. serum creatinine >3.0 mg/dL or >265 mcmol/L, known creatinine clearance <30mL/min or clinical markers of severe renal impairment)
  6. bilateral renal artery stenosis or renal artery stenosis in a solitary kidney or post-renal transplant
  7. clinically relevant hyperkalaemia
  8. uncorrected volume or sodium depletion.
  9. primary aldosteronism.
  10. hereditary fructose or lactose intolerance
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00558428

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

Responsible Party: Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair )
Study ID Numbers: 1235.5, EUDRACT2007-002409-36
Study First Received: October 29, 2007
Last Updated: October 6, 2008
ClinicalTrials.gov Identifier: NCT00558428  
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products;   Canada: Health Canada;   Denmark: Ethics Committee;   France: Afssaps - French Health Products Safety Agency;   Netherlands: The Central Committee on Research Involving Human Subjects (CCMO);   Norway: Norwegian Medicines Agency;   Taiwan: Department of Health;   South Korea: Korea Food and Drug Administration (KFDA);   Philippines: Department of Health;   Finland: Ethics Committee;   Sweden: Regional Ethical Review Board;   South Africa: Medicines Control Council;   United States: Food and Drug Administration

Study placed in the following topic categories:
Calcium, Dietary
Vascular Diseases
Telmisartan
Angiotensin II
Amlodipine
Hypertension

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

ClinicalTrials.gov processed this record on January 16, 2009