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: June 17, 2014
Last verified: May 2014
  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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]

    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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00558428

  Show 129 Study Locations
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: June 17, 2014
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
Telmisartan
Amlodipine
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on August 19, 2014