Study Evaluating the Efficacy of Nifedipine GITS - Telmisartan Combination in Blood Pressure Control.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00750113
First received: September 9, 2008
Last updated: November 12, 2013
Last verified: November 2013
  Purpose

Patients having uncontrolled or poorly controlled hypertension are at risk of experiencing cardiovascular events such as myocardial infarction or stroke. To reduce this risk an appropriate antihypertensive therapy should allow to reach a target blood pressure of less than 130/80 mmHg in order to maximise cardiovascular protection.The purpose of this study is to evaluate the efficacy in blood pressure control when anti-hypertensive therapy is initiated with a combination of low dose Nifedipine GITS and Telmisartan compared to a regimen starting with monotherapy before adding the other drug.The primary efficacy parameter will be the 24 hour mean systolic Blood Pressure on Ambulatory Blood Pressure Monitoring (ABPM) at 16 weeks of treatment compared to baseline


Condition Intervention Phase
Hypertension
Drug: Nifidipine
Drug: Telmisartan
Drug: Nifedipine/Telmisartan
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter Study Evaluating the Efficacy of Nifedipine GITS - Telmisartan Combination in Blood Pressure Control and Beyond: Comparison of Two Treatment Strategies.

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • The primary efficacy parameter will be the 24 hour mean systolic Blood Pressure on Ambulatory Blood Pressure Monitoring (ABPM) [ Time Frame: at 16 weeks of treatment compared to baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Office blood pressure, response rate (> 10mmHg decrease control rate (< 130/80) mean SBP, mean DBP. [ Time Frame: 8, 16 weeks of treatment ] [ Designated as safety issue: No ]
  • ABPM: % patients achieving BP < 125/80 mmHg morning BP increase/surge,24h mean diastolic BP,day average BP, night average BP,BP variability, pulse pressure through to peak ratio,smoothness index dipping or non dipping [ Time Frame: 8, 16 and 24 weeks ] [ Designated as safety issue: No ]
  • Microalbuminuria in subgroup (any reduction) [ Time Frame: 8, 16 and 24 weeks ] [ Designated as safety issue: No ]
  • Metabolic parameters: fasting blood glucose, total cholesterol, LDL cholesterol, HDL cholesterol, Triglycerides [ Time Frame: 8, 16 and 24 weeks ] [ Designated as safety issue: No ]
  • Inflammatory markers: sRAGE (soluble receptors for advanced glycation end products) eotaxin-3, CRP (C-Reactive Protein) [ Time Frame: 8, 16 and 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 405
Study Start Date: October 2007
Study Completion Date: August 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Nifidipine
Tablets 20 Mg daily for 4 weeks then combination therapy
Experimental: Arm 2 Drug: Telmisartan
Tablets 80 Mg daily for 4 weeks then combination therapy
Experimental: Arm 3 Drug: Nifedipine/Telmisartan
2 drugs (20 Mg Nifedipine/80 Mg Telmisartan) Combination therapy since the beginning

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hypertension (office systolic blood pressure > 135 mmHg), untreated or poorly controlled but stable antihypertensive regimen for >/= 4 weeks
  • Presence of type 2 diabetes mellitus or target organ damage (echocardiographic or electrocardiographic left ventricular hypertrophy or microalbuminuria)
  • Presence of a metabolic syndrome, i.e at least two of the following [(from letter (a) to letter(d)] in patients with organ damage or at least one of the following [from letter (b) to letter (d)] in patients with diabetes mellitus: (a) impaired glucose tolerance (fasting plasma glucose 110 -125 mg/dl) (b )raised serum triglycerides (>/= 150 mg/dl) or comitant use of statins for this indication(c) low HDL cholesterol (males: < 40 mg/dl, females: < 50 mg/dl)(d) waist circumference >102 cm in men and >88 cm in women
  • Age: 18-75 years
  • Negative pregnancy test in females
  • Written informed consent

Exclusion Criteria:

  • Concomitant treatment with AT1-antagonists e.g. losartan, eprosartan, telmisartan) or calcium-antagonists (e.g. amlodipine, felodipine, isradipine, nifedipine, nimodipine).
  • Concomitant treatment with any other antihypertensive medication that cannot be safely withdrawn at entry (i.e taken on a stable regimen for >/= 4 week) and that won't possibly be kept stable over the whole duration of the study.
  • Concomitant treatment with known cytochrome P450-3A4 inhibitors (e.g cimetidine, anti-HIV protease inhibitors e.g. ritonavir, azole anti-mycotics eg. Ketoconazole, digoxin, quinidine, tacrolimus) or inducers such as anti-epileptic drugs (eg. phenytoin, carbamazepine and phenobarbitone) or rifampicin
  • Concomitant treatment with potassium sparingdiuretics.
  • Malignant, severe or labile essential hypertension, orthostatic hypotension
  • Cardiovascular shock
  • Evidence of secondary form of hypertension, including coarctation of the aorta, hyperaldosteronism, renal artery stenosis or pheochromocytoma
  • Myocardial infarction or unstable angina within the previous 12 months
  • Severe cardiac valve disease
  • Severe rhythm or conduction disorder:
  • Cerebrovascular ischaemic event (stroke, transient ischaemic attack) within the previous 12 months
  • History of intra-cerebral haemorrhage or sub-arachnoid haemorrhage within the previous 12 months
  • Type 1 diabetes mellitus
  • Proteinuria (determined by uristix)
  • BMI > 34
  • Uncorrected hypokalemia or hyperkalemia, potassium outside the range 3.0 to 5.5 mmol/l
  • Sodium depletion and/or hypovolemia
  • Gastrointestinal disease resulting in the potential for malabsorption)
  • Liver disease or transaminase (AST, ALT) levels > 3 x the upper limit of normal range.
  • Renal failure, creatinine >2.0 mg/dl
  • General Exclusion Criteria: any malignant disease that has required treatment within the last five years, dementia or psychosis, history of non-compliance, alcoholism or drug abuse, treatment with any other investigational drug in the 30 days prior to entering the study, pregnancy and lactation, known state of allergy or hypersensitivity to nifedipine or any other dihydropyridine or to telmisartan, any surgical or medical condition which at the discretion of the investigator place the subject at higher risk from his/her participation in the study or are likely to prevent the subject from complying with the requirements of the study or completing the trial period, history of non compliance to medical regimens or subjects unwilling to comply with the study protocol.
  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: NCT00750113

Locations
Italy
Pozzilli, Isernia, Italy, 86077
Monza, Monza-Brianza, Italy, 20052
Somma Lombardo, Varese, Italy, 21013
Ancona, Italy, 60126
Bologna, Italy, 40138
Brescia, Italy, 25123
Broni, Italy, 27043
Catania, Italy, 95126
Cinisello Balsamo, Italy, 20092
Ferrara, Italy, 44100
L'Aquila, Italy, 67100
Milano, Italy, 20143
Napoli, Italy, 80136
Napoli, Italy, 80141
Novara, Italy, 28100
Padova, Italy, 35128
Palermo, Italy, 90127
Pavia, Italy, 27100
Perugia, Italy, 06129
Pisa, Italy, 56126
Reggio Emilia, Italy, 42100
Roma, Italy, 00161
Roma, Italy, 00157
Roma, Italy, 00152
Sassari, Italy, 07100
Siena, Italy, 53100
Siracusa, Italy, 96100
Treviso, Italy, 31100
Trieste, Italy, 34149
Varese, Italy, 21100
Venezia, Italy, 30122
Spain
Ferrol, A Coruña, Spain, 15405
Gijón, Asturias, Spain, 33394
Badalona, Barcelona, Spain, 08916
Jerez de la Frontera, Cádiz, Spain, 11407
Las Palmas de Gran Canaria, Las Palmas, Spain, 35020
Beniganim, Valencia, Spain, 46830
Badajoz, Spain, 06080
Ciudad Real, Spain, 13005
Madrid, Spain, 28040
Madrid, Spain, 28041
Málaga, Spain, 29010
Valencia, Spain, 46006
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Publications:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00750113     History of Changes
Other Study ID Numbers: 12313, 2006-006436-22
Study First Received: September 9, 2008
Last Updated: November 12, 2013
Health Authority: European Union: European Medicines Agency
Italy: Ministry of Health
Spain: Ministry of Health

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Nifedipine
Telmisartan
Benzoates
Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Vasodilator 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 July 20, 2014