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

Sponsor:	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 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:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Amlodipine Amlodipine besylate Telmisartan

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

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 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 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 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 >= 0 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 telmisarta 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

Ability to provide written informed consent in accordance with Good Clinical Practice and local legislation
Age 18 years or older
Patients with severe hypertension as defined SBP greater than 180 mmHg and DBP greater than 95 mmHg at randomisation
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00860262

Show 137 Study Locations

Sponsors and Collaborators

Boehringer Ingelheim Pharmaceuticals

Investigators

Study Chair:

Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

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 18, 2012
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
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 May 24, 2012