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Trial record 31 of 101 for:    AMLODIPINE AND VALSARTAN

Safety, Tolerability, and Efficacy of Once Daily Amlodipine/Valsartan 5/80 as Compared to Amlodipine/Valsartan 5/40 or to Amlodipine 5 mg Monotherapy in Patients 65 Years of Age and Older With Essential Hypertension

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ClinicalTrials.gov Identifier: NCT00699192
Recruitment Status : Completed
First Posted : June 17, 2008
Results First Posted : June 6, 2011
Last Update Posted : June 6, 2011
Sponsor:
Information provided by:
Novartis

Tracking Information
First Submitted Date  ICMJE June 9, 2008
First Posted Date  ICMJE June 17, 2008
Results First Submitted Date  ICMJE January 11, 2011
Results First Posted Date  ICMJE June 6, 2011
Last Update Posted Date June 6, 2011
Study Start Date  ICMJE May 2008
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 4, 2011)
Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study (Week 8) [ Time Frame: Baseline to end of study (Week 8) ]
At study entry, blood pressure (BP) was measured in both arms with an automatic BP monitor. The arm with the higher systolic BP reading was used for all measurements throughout the study. At each study visit, 3 separate sitting BPs were obtained 23-26 hours post-dose with at least 2 minutes between measurements and with the cuff fully deflated. Mean BP was automatically calculated from the 3 readings. A negative change from baseline indicates lowered BP.
Original Primary Outcome Measures  ICMJE
 (submitted: June 13, 2008)
The overall reporting of adverse events, serious adverse events (SAEs) including death, discontinuation due to adverse events, and notable laboratory abnormalities. [ Time Frame: 8 weeks ]
Change History Complete list of historical versions of study NCT00699192 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 4, 2011)
  • Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study (Week 8) [ Time Frame: Baseline to end of study (Week 8) ]
    At study entry, blood pressure (BP) was measured in both arms with an automatic BP monitor. The arm with the higher systolic BP reading was used for all measurements throughout the study. At each study visit, 3 separate sitting BPs were obtained 23-26 hours post-dose with at least 2 minutes between measurements and with the cuff fully deflated. Mean BP was automatically calculated from the 3 readings. A negative change from baseline indicates lowered BP.
  • Percentage of Patients Achieving a Systolic Blood Pressure Response at Week 8 [ Time Frame: Baseline to end of study (Week 8) ]
    A systolic blood pressure response was defined as a msSBP < 140 mmHg or ≥ 15 mmHg reduction from baseline at the end of the study (Week 8). At study entry, blood pressure (BP) was measured in both arms with an automatic BP monitor. The arm with the higher systolic BP reading was used for all measurements throughout the study. At each study visit, 3 separate sitting BPs were obtained 23-26 hours post-dose with at least 2 minutes between measurements and with the cuff fully deflated. Mean BP was automatically calculated from the 3 readings.
  • Percentage of Patients Achieving Systolic Blood Pressure Control at the End of the Study (Week 8) [ Time Frame: End of study (Week 8) ]
    Systolic blood pressure control was defined as a msSBP < 140 mmHg at the end of the study (Week 8). At study entry, blood pressure (BP) was measured in both arms with an automatic BP monitor. The arm with the higher systolic BP reading was used for all measurements throughout the study. At each study visit, 3 separate sitting BPs were obtained 23-26 hours post-dose with at least 2 minutes between measurements and with the cuff fully deflated. Mean BP was automatically calculated from the 3 readings.
  • Percentage of Patients Achieving Overall Blood Pressure Control at the End of the Study (Week 8) [ Time Frame: End of study (Week 8) ]
    Overall blood pressure control was defined as a msSBP < 140 mmHg and msDBP < 90 mmHg at the end of the study (Week 8). At study entry, blood pressure (BP) was measured in both arms with an automatic BP monitor. The arm with the higher systolic BP reading was used for all measurements throughout the study. At each study visit, 3 separate sitting BPs were obtained 23-26 hours post-dose with at least 2 minutes between measurements and with the cuff fully deflated. Mean BP was automatically calculated from the 3 readings.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 13, 2008)
  • To evaluate: aml/val 5/80mg compared to aml 5 mg monotherapy, [ Time Frame: 8 weeks ]
  • To evaluate aml/val 5/40mg to aml 5 mg monotherapy [ Time Frame: 8 weeks ]
  • To evaluate blood pressure lowering effects [ Time Frame: 8 weeks ]
  • To evaluate changes in orthostatic blood pressure, sitting and standing pulse, and laboratory data [ Time Frame: 8 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety, Tolerability, and Efficacy of Once Daily Amlodipine/Valsartan 5/80 as Compared to Amlodipine/Valsartan 5/40 or to Amlodipine 5 mg Monotherapy in Patients 65 Years of Age and Older With Essential Hypertension
Official Title  ICMJE A Multicenter, Double-blind, Randomized, Parallel-group Study to Evaluate the Safety, Tolerability, and Efficacy of Once Daily Amlodipine/Valsartan 5/80 mg as Compared to Amlodipine/Valsartan 5/40 mg or to Amlodipine 5 mg Once Daily in Elderly Patients With Essential Hypertension Not Adequately Controlled After Four Weeks on Amlodipine 5 mg Once Daily
Brief Summary To characterize the safety, tolerability, and efficacy profile of amlodipine/valsartan 5/80 mg as compared to amlodipine/valsartan 5/40 mg (with optional titration to 5/80 mg) and amlodipine 5 mg monotherapy in elderly patients (≥ 65 years of age) with essential hypertension. All three regimens are expected to be well tolerated.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Hypertension
Intervention  ICMJE
  • Drug: Amlodipine 5 mg
    1 capsule amlodipine 5 mg orally once daily
  • Drug: Valsartan 80 mg
    1 capsule valsartan 80 mg orally once daily
  • Drug: Valsartan 40 mg
    1 capsule valsartan 40 mg orally once daily
  • Drug: Placebo
    1 capsule placebo to match valsartan orally once daily
Study Arms  ICMJE
  • Experimental: Amlodipine/Valsartan 5/80 mg
    1 capsule amlodipine 5 mg, 1 capsule valsartan 80 mg once daily
    Interventions:
    • Drug: Amlodipine 5 mg
    • Drug: Valsartan 80 mg
  • Active Comparator: Amlodipine/Valsartan 5/40 mg
    1 capsule amlodipine 5 mg, 1 capsule valsartan 40 mg once daily
    Interventions:
    • Drug: Amlodipine 5 mg
    • Drug: Valsartan 40 mg
  • Active Comparator: Amlodipine 5 mg
    1 capsule amlodipine 5 mg, 1 capsule placebo to match valsartan once daily
    Interventions:
    • Drug: Amlodipine 5 mg
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 4, 2011)
965
Original Estimated Enrollment  ICMJE
 (submitted: June 13, 2008)
670
Actual Study Completion Date  ICMJE May 2009
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria

  • Provide written informed consent before any assessment was performed.
  • Male or female at least 65 years of age.
  • Diagnosed as having hypertension:

    • At Visit 1/Screening, treatment naïve patients had to have a mean seated SBP ≥ 155 mmHg and < 180 mmHg; patients undergoing washout from their previous antihypertension medication had to have a mean seated SBP <180 mmHg.
    • At Visit 2/Single-blind run-in entry, all patients had to have a mean seated SBP ≥ 155 mmHg and < 180 mmHg.
    • At Visit 3/Core double-blind treatment period entry, all patients had to have a mean seated SBP ≥ 145 mmHg and < 180 mmHg.
  • Ability to communicate and comply with all study requirements including measuring their blood pressure at home, daily as instructed, using the home blood pressure monitor provided by the Sponsor.
  • Female patients had to be post-menopausal for at least one year.

Exclusion criteria

  • Severe hypertension (mean seated SBP ≥ 180 mmHg and/or a mean seated DBP ≥ 110 mmHg).
  • History of secondary hypertension (including primary aldosteronism, renovascular hypertension, pheochromocytoma, etc.).
  • Use of three or more antihypertensive drugs. Dual fixed dose combination therapy was considered as two antihypertensive drugs.
  • Administration of any agent indicated for the treatment of hypertension after Visit 1, with the permitted exception of those antihypertensive medications requiring tapering down (e.g. beta-blocker and/or clonidine) commencing with Visit 1.
  • Known moderate or malignant retinopathy. Moderate was defined as retinal signs of hemorrhage, microaneurysm, cotton-wool spot, hard exudates, or a combination thereof; malignant defined as signs of moderate retinopathy plus swelling of the optic disk.
  • Known or suspected contraindications, including history of allergy or hypersensitivity to angiotensin receptor blockers (ARB), calcium channel blockers (CCB), or to drugs with similar chemical structures.
  • History of cerebrovascular accident, thrombotic stroke, or transient ischemic attack.
  • Significant history of coronary artery disease (CAD) such as any history of myocardial infarction (MI), angina pectoris, and all types of revascularization procedures.
  • History of or diagnosis of congestive heart failure Grade II-IV according to the New York Heart Association (NYHA) classification.
  • Clinically significant valvular heart disease.
  • All patients with Type 1 diabetes mellitus and those patients with Type 2 diabetes mellitus who, in the opinion of the investigator, were not well controlled. Patients who needed oral anti-diabetic medication to adequately control their Type 2 diabetes had to be on a stable dose of oral anti-diabetic medication for at least 4 weeks prior to Visit 1.
  • Concomitant potentially life threatening arrhythmia or symptomatic arrhythmia.
  • Second or third degree heart block with or without a pacemaker.
  • Significant hepatic disease, as demonstrated by any one of the following: aspartate aminotransferase (AST) or alanine aminotransferase (ALT) values greater than two times the upper limit of normal at Visit 1, a history of hepatic encephalopathy, a history of esophageal varices, or a history of a portocaval shunt.
  • Evidence of renal impairment as determined by any one of the following: glomerular filtration rate (GFR) < 50 ml/min/1.73m2 as measured by the Modification of Diet in Renal Disease (MDRD) formula at Visit 1, a history of dialysis, or a history of nephrotic syndrome.
  • History of clinically significant allergies including asthma and/or multiple drug allergies.
  • Any surgical or medical condition with the potential to significantly alter the absorption, distribution, metabolism, or excretion of any drug including but not limited to any of the following: history of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, bowel resection, gastric bypass, gastric stapling, or gastric banding, currently active or inactive inflammatory bowel syndrome within 12 months prior to Visit 1, currently active gastritis, ulcers, or gastrointestinal/rectal bleeding, or urinary tract obstruction regarded as clinically meaningful by the investigator.
  • Any condition, not identified in the protocol, that, in the opinion of the investigator or the Novartis monitor, placed the patient at higher risk from his/her participation in the study, or was likely to prevent the patient from complying with the requirement of the study or completing the trial period.
  • History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there was evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin.
  • Any chronic inflammatory condition needing chronic anti-inflammatory therapy.
  • History of drug or alcohol abuse within the last 2 years.
  • Use of investigational drugs at the time of enrollment, or within 30 days prior to Visit 1 (Week 8).
  • Inability to communicate and comply with all study requirements including the unwillingness or inability to provide informed consent.
  • Persons directly involved in the execution of this protocol.
  • History of non-compliance to medical regimens, or patients unwilling to comply with the study protocol.
  • Any severe, life-threatening disease within the past five years.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Czech Republic,   Finland,   France,   Germany,   Hungary,   Italy,   Poland,   Slovakia,   Spain,   Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00699192
Other Study ID Numbers  ICMJE CVAA489A2318
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party External Affairs, Novartis Pharmaceuticals
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP