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

This study is currently recruiting participants.
Verified by Bayer, September 2008

Sponsored by: Bayer
Information provided by: Bayer
ClinicalTrials.gov Identifier: NCT00750113
  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: Nifedipine
Drug: Telmisartan
Drug: Nifedipine/Telmisartan
Phase IV

MedlinePlus related topics:   High Blood Pressure   

ChemIDplus related topics:   Nifedipine    Telmisartan   

U.S. FDA Resources

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

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 ]

Estimated Enrollment:   445
Study Start Date:   October 2007
Estimated Study Completion Date:   June 2009
Estimated Primary Completion Date:   April 2009 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Arm 1: Experimental Drug: Nifedipine
Tablets 20 Mg daily for 4 weeks then combination therapy
Arm 2: Experimental Drug: Telmisartan
Tablets 80 Mg daily for 4 weeks then combination therapy
Arm 3: Experimental 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 110 182 125 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 won178t 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 sparing diuretics.
  • 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00750113

Contacts
Contact: Bayer Clinical Trials Contact     clinical-trials-contact@bayerhealthcare.com    

Show 37 study locations  Show 37 Study Locations

Sponsors and Collaborators
Bayer

Investigators
Study Director:     Bayer Study Director     Bayer    
  More Information


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Responsible Party:   ( Medical Affairs Therapeutic Area Head )
Study ID Numbers:   12313, 2006-006436-22
First Received:   September 9, 2008
Last Updated:   September 9, 2008
ClinicalTrials.gov Identifier:   NCT00750113
Health Authority:   European Union: European Medicines Agency;   Italy: Ministry of Health;   Spain: Ministry of Health;   United States: Food and Drug Administration

Study placed in the following topic categories:
Vascular Diseases
Telmisartan
Angiotensin II
Nifedipine
Hypertension

Additional relevant MeSH terms:
Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Calcium Channel Blockers
Enzyme Inhibitors
Cardiovascular Agents
Reproductive Control Agents
Pharmacologic Actions
Protease Inhibitors
Membrane Transport Modulators
Angiotensin II Type 1 Receptor Blockers
Tocolytic Agents
Therapeutic Uses
Angiotensin-Converting Enzyme Inhibitors
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 06, 2008




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