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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00750113
Recruitment Status : Completed
First Posted : September 10, 2008
Last Update Posted : December 5, 2014
Information provided by (Responsible Party):

Brief Summary:
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 or disease Intervention/treatment Phase
Hypertension Drug: Nifidipine Drug: Telmisartan Drug: Nifedipine/Telmisartan Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 405 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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.
Study Start Date : October 2007
Actual Primary Completion Date : July 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Office blood pressure, response rate (> 10mmHg decrease control rate (< 130/80) mean SBP, mean DBP. [ Time Frame: 8, 16 weeks of treatment ]
  2. 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 ]
  3. Microalbuminuria in subgroup (any reduction) [ Time Frame: 8, 16 and 24 weeks ]
  4. Metabolic parameters: fasting blood glucose, total cholesterol, LDL cholesterol, HDL cholesterol, Triglycerides [ Time Frame: 8, 16 and 24 weeks ]
  5. Inflammatory markers: sRAGE (soluble receptors for advanced glycation end products) eotaxin-3, CRP (C-Reactive Protein) [ Time Frame: 8, 16 and 24 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00750113

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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, 00152
Roma, Italy, 00157
Roma, Italy, 00161
Sassari, Italy, 07100
Siena, Italy, 53100
Siracusa, Italy, 96100
Treviso, Italy, 31100
Trieste, Italy, 34149
Varese, Italy, 21100
Venezia, Italy, 30122
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
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Study Director: Bayer Study Director Bayer
Additional Information:
Publications of Results:
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Responsible Party: Bayer Identifier: NCT00750113    
Other Study ID Numbers: 12313
2006-006436-22 ( EudraCT Number )
First Posted: September 10, 2008    Key Record Dates
Last Update Posted: December 5, 2014
Last Verified: December 2014
Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Calcium Channel Blockers
Membrane Transport Modulators
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Tocolytic Agents
Reproductive Control Agents