Telmisartan and Amlodipine Fixed Dose Combination [FDC] Trial for the Treatment of Severe Hypertension

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00860262
First received: March 11, 2009
Last updated: May 16, 2014
Last verified: May 2014
  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 Systolic Blood Pressure [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: amlodipine
Drug: telmisartan
Drug: telmisartan and amlodipine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: An 8-week Randomised, Double-blind Study to Compare the Fixed-dose Combination of Telmisartan 80 mg & Amlodipine 10mg Versus Telmisartan 80 mg Monotherapy or Amlodipine 10 mg Monotherapy as First Line Therapy in Patients With Severe Hypertension (Grade 3).

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Change From Baseline in Trough Seated Systolic Blood Pressure (SBP) at Week 8 [ Time Frame: baseline and week 8 ] [ Designated as safety issue: No ]
    Overall mean reduction from a common mean baseline in SBP


Secondary Outcome Measures:
  • Change From Baseline in Trough Seated Systolic Blood Pressure at Week 6 [ Time Frame: baseline and week 6 ] [ Designated as safety issue: No ]
    Overall mean reduction from a common mean baseline in SBP

  • Change From Baseline in Trough Seated Systolic Blood Pressure at Week 4 [ Time Frame: baseline and week 4 ] [ Designated as safety issue: No ]
    Overall mean reduction from a common mean baseline in SBP

  • Change From Baseline in Trough Seated Systolic Blood Pressure at Week 2 [ Time Frame: baseline and week 2 ] [ Designated as safety issue: No ]
    Overall mean reduction from a common mean baseline in SBP

  • Change From Baseline in Trough Seated Systolic Blood Pressure at Week 1 [ Time Frame: baseline and week 1 ] [ Designated as safety issue: No ]
    Overall mean reduction from a common mean baseline in SBP

  • Change From Baseline in Trough Seated Diastolic Blood Pressure (DBP) at Week 8 [ Time Frame: baseline and week 8 ] [ Designated as safety issue: No ]
    Overall mean reduction from a common mean baseline in DBP

  • Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 6 [ Time Frame: baseline and week 6 ] [ Designated as safety issue: No ]
    Overall mean reduction from a common mean baseline in DBP

  • Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 4 [ Time Frame: baseline and week 4 ] [ Designated as safety issue: No ]
    Overall mean reduction from a common mean baseline in DBP

  • Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 2 [ Time Frame: baseline and week 2 ] [ Designated as safety issue: No ]
    Overall mean reduction from a common mean baseline in DBP

  • Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 1 [ Time Frame: baseline and week 1 ] [ Designated as safety issue: No ]
    Overall mean reduction from a common mean baseline in DBP

  • Patients Achieving Diastolic Blood Pressure Control at Week 1 [ Time Frame: week 1 ] [ Designated as safety issue: No ]
    Diastolic Blood Pressure Control is defined as achieving DBP < 90mmHg

  • Patients Achieving Diastolic Blood Pressure Control at Week 2 [ Time Frame: week 2 ] [ Designated as safety issue: No ]
    DBP < 90 mmHg

  • Patients Achieving Blood Pressure Control at Week 1 [ Time Frame: week 1 ] [ Designated as safety issue: No ]
    Blood Pressure Control is defined as achieving SBP< 140 mmHg and DBP < 90mmHg

  • Patients Achieving Blood Pressure Control at Week 2 [ Time Frame: week 2 ] [ Designated as safety issue: No ]
    SBP < 140 mmHg and DBP < 90 mmHg

  • Patients Achieving Diastolic Blood Pressure Response at Week 1 [ Time Frame: baseline, week 1 ] [ Designated as safety issue: No ]
    Diastolic Blood Pressure Response is defined as achieving DBP < 90 mmHg or a reduction of >= 10 mmHg

  • Patients Achieving Diastolic Blood Pressure Response at Week 2 [ Time Frame: baseline, week 2 ] [ Designated as safety issue: No ]
    DBP < 90 mmHg or reduction of >= 10 mmHg

  • Patients Achieving Systolic Blood Pressure Response at Week 1 [ Time Frame: baseline, week 1 ] [ Designated as safety issue: No ]
    Systolic Blood Pressure Response Control is defined as achieving SBP < 140 mmHg or a reduction of >= 15 mmHg

  • Patients Achieving Systolic Blood Pressure Response at Week 2 [ Time Frame: baseline, week 2 ] [ Designated as safety issue: No ]
    SBP < 140 mmHg or reduction of >= 15 mmHg

  • Number of Patients Achieving Various Blood Pressure Response Levels at Week 1 [ Time Frame: week 1 ] [ Designated as safety issue: No ]
    Optimal: SBP<120 and DBP< 80; Normal: 120<=SBP<130 and 80<= DBP<85; High normal: 130<=SBP<140 and 85<=DBP<90; High: SBP>=140 or DBP>=90

  • Number of Patients Achieving Various Blood Pressure Response Levels at Week 2 [ Time Frame: week 2 ] [ Designated as safety issue: No ]
    Optimal: SBP<120 and DBP< 80; Normal: 120<=SBP<130 and 80<= DBP<85; High normal: 130<=SBP<140 and 85<=DBP<90; High: SBP>=140 or DBP>=90

  • Patients Achieving Diastolic Blood Pressure Control at Week 4 [ Time Frame: week 4 ] [ Designated as safety issue: No ]
    DBP < 90 mmHg

  • Patients Achieving Diastolic Blood Pressure Control at Week 6 [ Time Frame: week 6 ] [ Designated as safety issue: No ]
    DBP < 90 mmHg

  • Patients Achieving Diastolic Blood Pressure Control at Week 8 [ Time Frame: week 8 ] [ Designated as safety issue: No ]
    DBP < 90 mmHg

  • Patients Achieving Blood Pressure Control at Week 4 [ Time Frame: week 4 ] [ Designated as safety issue: No ]
    SBP < 140 mmHg and DBP < 90 mmHg

  • Patients Achieving Blood Pressure Control at Week 6 [ Time Frame: week 6 ] [ Designated as safety issue: No ]
    SBP < 140 mmHg and DBP < 90 mmHg

  • Patients Achieving Blood Pressure Control at Week 8 [ Time Frame: week 8 ] [ Designated as safety issue: No ]
    SBP < 140 mmHg and DBP < 90 mmHg

  • Patients Achieving Diastolic Blood Pressure Response at Week 4 [ Time Frame: baseline, week 4 ] [ Designated as safety issue: No ]
    DBP < 90 mmHg or reduction of >= 10 mmHg

  • Patients Achieving Diastolic Blood Pressure Response at Week 6 [ Time Frame: baseline, week 6 ] [ Designated as safety issue: No ]
    DBP < 90 mmHg or reduction of >= 10 mmHg

  • Patients Achieving Diastolic Blood Pressure Response at Week 8 [ Time Frame: baseline, week 8 ] [ Designated as safety issue: No ]
    DBP < 90 mmHg or reduction of >= 10 mmHg

  • Patients Achieving Systolic Blood Pressure Response at Week 4 [ Time Frame: baseline, week 4 ] [ Designated as safety issue: No ]
    SBP < 140 mmHg or reduction of >= 15 mmHg

  • Patients Achieving Systolic Blood Pressure Response at Week 6 [ Time Frame: baseline, week 6 ] [ Designated as safety issue: No ]
    SBP < 140 mmHg or reduction of >= 15 mmHg

  • Patients Achieving Systolic Blood Pressure Response at Week 8 [ Time Frame: baseline, week 8 ] [ Designated as safety issue: No ]
    SBP < 140 mmHg or reduction of >= 15 mmHg

  • Patients Achieving Normal Blood Pressure Response at Week 4 [ Time Frame: week 4 ] [ Designated as safety issue: No ]
    Optimal: SBP<120 and DBP< 80; Normal: 120<=SBP<130 and 80<= DBP<85; High normal: 130<=SBP<140 and 85<=DBP<90; High: SBP>=140 or DBP>=90

  • Patients Achieving Normal Blood Pressure Response at Week 6 [ Time Frame: week 6 ] [ Designated as safety issue: No ]
    Optimal: SBP<120 and DBP< 80; Normal: 120<=SBP<130 and 80<= DBP<85; High normal: 130<=SBP<140 and 85<=DBP<90; High: SBP>=140 or DBP>=90

  • Patients Achieving Normal Blood Pressure Response at Week 8 [ Time Frame: week 8 ] [ Designated as safety issue: No ]
    Optimal: SBP<120 and DBP< 80; Normal: 120<=SBP<130 and 80<= DBP<85; High normal: 130<=SBP<140 and 85<=DBP<90; High: SBP>=140 or DBP>=90


Enrollment: 858
Study Start Date: March 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: telmisartan and amlodipine
telmisartan and amlodipine used in combination vs amlodipine or telmisartan
Drug: telmisartan and amlodipine
telmisartan 80 and amlodipine 5mg for the first 2 weeks, then force titrated to telmisartan 80mg and amlodipine 10mg for the remaining 6w
Active Comparator: amlodipine
telmisartan and amlodipine used in combination vs amlodipine or telmisartan
Drug: amlodipine
amlodipine 5mg for the first 2w then force titration to Amlodipine 10mg for remaining 6 w
Active Comparator: telmisartan
telmisartan and amlodipine used in combination vs amlodipine or telmisartan
Drug: telmisartan
telmisartan 80mg for the 8w, no titration required

  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 Mean in-clinic seated cuff SBP >/= 200 mmHg and/or Diastolic Blood Pressure [DBP] >/= 95 mmHg

  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: NCT00860262

  Show 137 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: NCT00860262     History of Changes
Other Study ID Numbers: 1235.20, 2008-000873-40
Study First Received: March 11, 2009
Results First Received: December 10, 2010
Last Updated: May 16, 2014
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

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

ClinicalTrials.gov processed this record on October 19, 2014