Telmisartan/Amlodipine (80/5) vs. Telmisartan/Amlodipine (40/5) vs. Amlodipine 10 or 5 in Resistant Hypertension

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00558428
First received: October 29, 2007
Last updated: May 18, 2012
Last verified: May 2012
  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 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Change From Baseline in Trough Seated Diastolic Blood Pressure (DBP) [ Time Frame: End of study (8 weeks or last value on treatment) ]
    Change from baseline to the end of study in trough DBP

  • Number of Patients With Oedema [ Time Frame: During randomised treatment period (8 weeks was the planned end of treatment, some of the measurements analysed as end of study can be at 4 weeks or at any point on randomised treatment) ]
    Patients from the treated set who experienced at least one case of general oedema.


Secondary Outcome Measures:
  • Change From Baseline in Trough Seated Systolic Blood Pressure (SBP) [ Time Frame: End of study (8 weeks or last value on treatment) ]
    Change from baseline to the end of study in trough SBP

  • Trough Seated Diastolic Blood Pressure Control [ Time Frame: End of study (8 weeks or last value on treatment) ]
    The number of patients who reach the target DBP of <90mmHg

  • Trough Seated DBP Response [ Time Frame: End of study (8 weeks or last value on treatment) ]
    The number of patients who reach the target DBP of <90mmHg or had a reduction in DBP >= 10mmHg

  • Trough Seated SBP Control [ Time Frame: End of study (8 weeks or last value on treatment) ]
    The number of patients who reach the target SBP of <140mmHg

  • Trough Seated SBP Response [ Time Frame: End of study (8 weeks or last value on treatment) ]
    The number of patients who reach the target SBP of <140mmHg or had a reduction in SBP >= 15 mmHg

  • Trough Seated Blood Pressure (BP) Normality Classes [ Time Frame: End of study (8 weeks or last value on treatment) ]

    The number of patients who reach predefined BP categories:

    • Optimal - SBP<120 and DBP<80 mmHg
    • Normal - SBP<130 and DBP<85 mmHg
    • High-normal - SBP<140 DBP<90 mmHg
    • Stage 1 hypertension - SBP<160 and DBP<100
    • Stage 2 hypertension SBP>=160 and DBP>=100 mmHg


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 systolic blood pressure (SBP) over 200 mmHg and/or mean seated diastolic blood pressure (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

  Hide Study Locations
Locations
Belgium
1235.5.32004 Boehringer Ingelheim Investigational Site
Aywaille, Belgium
1235.5.32001 Boehringer Ingelheim Investigational Site
Bruxelles, Belgium
1235.5.32010 Boehringer Ingelheim Investigational Site
Gozée, Belgium
1235.5.32008 Boehringer Ingelheim Investigational Site
Linkebeek, Belgium
1235.5.32003 Boehringer Ingelheim Investigational Site
Mol, Belgium
1235.5.32007 Boehringer Ingelheim Investigational Site
Natoye, Belgium
1235.5.32009 Boehringer Ingelheim Investigational Site
Tavier, Belgium
1235.5.32002 Boehringer Ingelheim Investigational Site
Tienen-Kumtich, Belgium
1235.5.32005 Boehringer Ingelheim Investigational Site
Turnhout, Belgium
Canada, British Columbia
1235.5.20001 Boehringer Ingelheim Investigational Site
Coquitlam, British Columbia, Canada
1235.5.20011 Boehringer Ingelheim Investigational Site
Vancouver, British Columbia, Canada
Canada, Newfoundland and Labrador
1235.5.20007 Boehringer Ingelheim Investigational Site
Bay Roberts, Newfoundland and Labrador, Canada
1235.5.20005 Boehringer Ingelheim Investigational Site
Mount Pearl, Newfoundland and Labrador, Canada
1235.5.20008 Boehringer Ingelheim Investigational Site
St. John's, Newfoundland and Labrador, Canada
Canada, Ontario
1235.5.20013 Boehringer Ingelheim Investigational Site
Corunna, Ontario, Canada
1235.5.20014 Boehringer Ingelheim Investigational Site
Etobicoke, Ontario, Canada
1235.5.20010 Boehringer Ingelheim Investigational Site
Hamilton, Ontario, Canada
1235.5.20012 Boehringer Ingelheim Investigational Site
London, Ontario, Canada
1235.5.20009 Boehringer Ingelheim Investigational Site
Ottawa, Ontario, Canada
1235.5.20006 Boehringer Ingelheim Investigational Site
Sarnia, Ontario, Canada
Canada, Quebec
1235.5.20003 Boehringer Ingelheim Investigational Site
Sainte-Foy, Quebec, Canada
Denmark
1235.5.45002 Boehringer Ingelheim Investigational Site
Birkerød, Denmark
1235.5.45005 Boehringer Ingelheim Investigational Site
Haderslev, Denmark
1235.5.45008 Boehringer Ingelheim Investigational Site
Herning, Denmark
1235.5.45009 Boehringer Ingelheim Investigational Site
Hinnerup, Denmark
1235.5.45006 Boehringer Ingelheim Investigational Site
Rødovre, Denmark
1235.5.45001 Boehringer Ingelheim Investigational Site
Rødovre, Denmark
1235.5.45003 Boehringer Ingelheim Investigational Site
Vaerløse, Denmark
1235.5.45007 Boehringer Ingelheim Investigational Site
Vildbjerg, Denmark
Finland
1235.5.35003 Boehringer Ingelheim Investigational Site
Joensuu, Finland
1235.5.35004 Boehringer Ingelheim Investigational Site
Joensuu, Finland
1235.5.35002 Boehringer Ingelheim Investigational Site
Turku, Finland
1235.5.35001 Boehringer Ingelheim Investigational Site
Turku, Finland
France
1235.5.3301H Boehringer Ingelheim Investigational Site
Aigrefeuille S/Maine, France
1235.5.3306C Boehringer Ingelheim Investigational Site
Angers, France
1235.5.3309B Boehringer Ingelheim Investigational Site
Angers, France
1235.5.3309E Boehringer Ingelheim Investigational Site
Angers, France
1235.5.3309C Boehringer Ingelheim Investigational Site
Angers, France
1235.5.3309D Boehringer Ingelheim Investigational Site
Avrille, France
1235.5.3309A Boehringer Ingelheim Investigational Site
Beaucouze, France
1235.5.3305A Boehringer Ingelheim Investigational Site
Bourg des cptes, France
1235.5.3306D Boehringer Ingelheim Investigational Site
Briollay, France
1235.5.3308C Boehringer Ingelheim Investigational Site
Cholet, France
1235.5.3308B Boehringer Ingelheim Investigational Site
Cholet, France
1235.5.3308F Boehringer Ingelheim Investigational Site
Cholet, France
1235.5.3308D Boehringer Ingelheim Investigational Site
Cholet, France
1235.5.3302C Boehringer Ingelheim Investigational Site
Garchizy, France
1235.5.3303C Boehringer Ingelheim Investigational Site
Grandchamps, France
1235.5.3302D Boehringer Ingelheim Investigational Site
Guerigny, France
1235.5.3310A Boehringer Ingelheim Investigational Site
Jarny, France
1235.5.3301L Boehringer Ingelheim Investigational Site
La Chapelle /s Erdre, France
1235.5.3301J Boehringer Ingelheim Investigational Site
La Chapelle sur Erdre, France
1235.5.3304A Boehringer Ingelheim Investigational Site
La Fresnais, France
1235.5.3308E Boehringer Ingelheim Investigational Site
La Jubaudière, France
1235.5.3301G Boehringer Ingelheim Investigational Site
La Montagne, France
1235.5.3303B Boehringer Ingelheim Investigational Site
Le Bono, France
1235.5.3307D Boehringer Ingelheim Investigational Site
Le Mesnil en Vallée, France
1235.5.3301E Boehringer Ingelheim Investigational Site
Le Temple de Bretagne, France
1235.5.3309F Boehringer Ingelheim Investigational Site
Les Ponts de CE, France
1235.5.3307G Boehringer Ingelheim Investigational Site
Loudun, France
1235.5.3305B Boehringer Ingelheim Investigational Site
Louvigné le Bais, France
1235.5.3307E Boehringer Ingelheim Investigational Site
Mouliherne, France
1235.5.3306A Boehringer Ingelheim Investigational Site
Murs Erigne, France
1235.5.3307A Boehringer Ingelheim Investigational Site
Murs-Erigne, France
1235.5.3301D Boehringer Ingelheim Investigational Site
Nantes, France
1235.5.3301M Boehringer Ingelheim Investigational Site
Nantes, France
1235.5.3301B Boehringer Ingelheim Investigational Site
Nantes, France
1235.5.3301A Boehringer Ingelheim Investigational Site
Nantes, France
1235.5.3302A Boehringer Ingelheim Investigational Site
Nevers, France
1235.5.3302F Boehringer Ingelheim Investigational Site
Nevers, France
1235.5.3301I Boehringer Ingelheim Investigational Site
Nort sur Erdre, France
1235.5.3301C Boehringer Ingelheim Investigational Site
Orvault, France
1235.5.3307F Boehringer Ingelheim Investigational Site
Parcay les Pins, France
1235.5.3307C Boehringer Ingelheim Investigational Site
Saint Pierre Montlimard, France
1235.5.3301N Boehringer Ingelheim Investigational Site
Sautron, France
1235.5.3306B Boehringer Ingelheim Investigational Site
Segre, France
1235.5.3301F Boehringer Ingelheim Investigational Site
St Aubin les Châteaux, France
1235.5.3306F Boehringer Ingelheim Investigational Site
St Georges de Montaigu, France
1235.5.3304B Boehringer Ingelheim Investigational Site
St Ouen La Rouerie, France
1235.5.3306E Boehringer Ingelheim Investigational Site
Thouars, France
1235.5.3304C Boehringer Ingelheim Investigational Site
Tinténiac, France
1235.5.3303A Boehringer Ingelheim Investigational Site
Vannes, France
1235.5.3308A Boehringer Ingelheim Investigational Site
Vihiers, France
Korea, Republic of
1235.5.82007 Boehringer Ingelheim Investigational Site
Busan, Korea, Republic of
1235.5.82001 Boehringer Ingelheim Investigational Site
Daegu, Korea, Republic of
1235.5.82006 Boehringer Ingelheim Investigational Site
Daejon, Korea, Republic of
1235.5.82004 Boehringer Ingelheim Investigational Site
Gangwon-Do, Korea, Republic of
1235.5.82008 Boehringer Ingelheim Investigational Site
Gwangju, Korea, Republic of
1235.5.82005 Boehringer Ingelheim Investigational Site
Seoul, Korea, Republic of
1235.5.82002 Boehringer Ingelheim Investigational Site
Seoul, Korea, Republic of
1235.5.82003 Boehringer Ingelheim Investigational Site
Seoul, Korea, Republic of
Netherlands
1235.5.31008 Boehringer Ingelheim Investigational Site
Beerzerveld, Netherlands
1235.5.31006 Boehringer Ingelheim Investigational Site
Bennebroek, Netherlands
1235.5.31004 Boehringer Ingelheim Investigational Site
Hoogwoud, Netherlands
1235.5.31003 Boehringer Ingelheim Investigational Site
Musselkanaal, Netherlands
1235.5.31007 Boehringer Ingelheim Investigational Site
Nijverdal, Netherlands
1235.5.31001 Boehringer Ingelheim Investigational Site
Oude Pekela, Netherlands
1235.5.31005 Boehringer Ingelheim Investigational Site
Roelofarendsveen, Netherlands
1235.5.31010 Boehringer Ingelheim Investigational Site
Voerendaal, Netherlands
Norway
1235.5.47002 Boehringer Ingelheim Investigational Site
Bergen, Norway
1235.5.47003 Boehringer Ingelheim Investigational Site
Hamar, Norway
1235.5.47004 Boehringer Ingelheim Investigational Site
Oslo, Norway
1235.5.47001 Boehringer Ingelheim Investigational Site
Ålesund, Norway
Philippines
1235.5.63006 Boehringer Ingelheim Investigational Site
Makati City, Philippines
1235.5.63001 Boehringer Ingelheim Investigational Site
Manila, Philippines
1235.5.63002 Boehringer Ingelheim Investigational Site
Manila, Philippines
1235.5.63009 Boehringer Ingelheim Investigational Site
Manila, Philippines
1235.5.63008 Boehringer Ingelheim Investigational Site
Pasay City, Philippines
1235.5.63005 Boehringer Ingelheim Investigational Site
Pasig City, Philippines
1235.5.63007 Boehringer Ingelheim Investigational Site
Quezon City, Philippines
1235.5.63003 Boehringer Ingelheim Investigational Site
Quezon City, Philippines
South Africa
1235.5.27003 Boehringer Ingelheim Investigational Site
Boksburg, South Africa
1235.5.27006 Boehringer Ingelheim Investigational Site
Cape Town, South Africa
1235.5.27010 Boehringer Ingelheim Investigational Site
Cape Town, South Africa
1235.5.27009 Boehringer Ingelheim Investigational Site
Cape Town, South Africa
1235.5.27004 Boehringer Ingelheim Investigational Site
Durban, South Africa
1235.5.27008 Boehringer Ingelheim Investigational Site
Johannesburg, South Africa
1235.5.27001 Boehringer Ingelheim Investigational Site
Krugersdorp, South Africa
1235.5.27005 Boehringer Ingelheim Investigational Site
Lenasia, South Africa
1235.5.27002 Boehringer Ingelheim Investigational Site
Pretoria, South Africa
Sweden
1235.5.46002 Boehringer Ingelheim Investigational Site
Göteborg, Sweden
1235.5.46003 Boehringer Ingelheim Investigational Site
Göteborg, Sweden
1235.5.46005 Boehringer Ingelheim Investigational Site
Luleå, Sweden
1235.5.46004 Boehringer Ingelheim Investigational Site
Rättvik, Sweden
1235.5.46001 Boehringer Ingelheim Investigational Site
Stockholm, Sweden
Taiwan
1235.5.88605 Boehringer Ingelheim Investigational Site
Changhua, Taiwan
1235.5.88608 Boehringer Ingelheim Investigational Site
Hualien City, Taiwan
1235.5.88601 Boehringer Ingelheim Investigational Site
Kaohsiung, Taiwan
1235.5.88603 Boehringer Ingelheim Investigational Site
Taichung, Taiwan
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00558428     History of Changes
Other Study ID Numbers: 1235.5, EUDRACT2007-002409-36
Study First Received: October 29, 2007
Results First Received: November 13, 2009
Last Updated: May 18, 2012
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
Canada: Health Canada (TPD)
Denmark: Lægemiddelstyrelsen Kliniskeforsøg, Inspektionen Axel Heides Gade 1 DK-2300 Copenhagen S
Finland: HUS Ethics Committee
France: AGENCE FRANCAISE DE SECURITE SANITAIRE DES PRODUITS DE SANTE
Korea, Republic of: Korea Food and Drug Administration (KFDA)
Netherlands: Central Committee on Research Involving Human Subjects (CCMO)
Norway: Norwegian Medicines Agency (Statens Legemiddelverk)
Philippines: Department of Health, Republic of the Philippines
South Africa: Medicines Control Council
Sweden: Regional Ethics Committee of Stockholm, PO Box 289, SE-17177 Stockholm, Sweden. Medical Products Agency
Taiwan: Department of Health, Executive Yuan, Taiwan
United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 21, 2014