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Trial record 25 of 101 for:    AMLODIPINE AND VALSARTAN

Study of Efficacy and Safety of CVAA489 in Hypertensive Patients

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.
 
ClinicalTrials.gov Identifier: NCT02062645
Recruitment Status : Completed
First Posted : February 14, 2014
Results First Posted : March 28, 2017
Last Update Posted : March 28, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date  ICMJE February 12, 2014
First Posted Date  ICMJE February 14, 2014
Results First Submitted Date  ICMJE November 15, 2016
Results First Posted Date  ICMJE March 28, 2017
Last Update Posted Date March 28, 2017
Study Start Date  ICMJE February 2014
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 7, 2017)
Percentage of Participants With Blood Pressure (BP) <140/90 mmHg at Week 4 and 8 [ Time Frame: At week 4 and 8 ]
Control rate of BP defined as BP lower than 140/90 mmHg at office visits
Original Primary Outcome Measures  ICMJE
 (submitted: February 12, 2014)
Percentage of patients with control rate of blood pressure (BP) [ Time Frame: 2 months ]
Control rate of BP defined as BP lower than 140/90 mmHg.
Change History Complete list of historical versions of study NCT02062645 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 7, 2017)
  • Systolic Blood Pressure (SBP) at Baseline, Week 4 and 8 [ Time Frame: baseline, week 4, week 8 ]
    Change in systolic blood pressure measured in office from baseline at week 4 and 8.
  • Diastolic Blood Pressure (DBP) at Baseline, Week 4 and 8 [ Time Frame: baseline, week 4, week 8 ]
    Change in diastolic blood pressure measured in office from baseline at week 4 and week 8.
  • Percentage of Participants With High Sodium Intake and Blood Pressure (BP) <140/90 mmHg at Week 4 and 8 [ Time Frame: At week 4 and 8 ]
    Control rate of BP is defined as blood pressure lower than 140/90 mmHg at office visits in patients with high sodium intake (>100 mEq/day)
  • SBP and DBP in Patients With High Sodium Intake at Week 4 and 8 [ Time Frame: At week 4 and 8 ]
    Change in systolic and diastolic blood pressure measured in office from baseline at week 4 and 8.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 12, 2014)
  • Change from baseline in systolic blood pressure (SBP) in patients treated with valsartan/amlodipine at 2 months [ Time Frame: baseline, 2 months ]
    All patient will have office BP monitoring in the clinic in each visit.
  • Change from baseline in diastolic blood pressure (DBP) in patients treated with valsartan/amlodipine at 2 months [ Time Frame: baseline, 2 months ]
    All patient will have office BP monitoring in the clinic in each visit.
  • Change from baseline control rate of BP in patients with high sodium intake at 2 months [ Time Frame: baseline, 2 months ]
    All patient will have office BP monitoring in the clinic in each visit. Control rate of BP defined as BP lower than 140/90 mmHg.
  • Change from baseline in SBP and DBP in patients with high sodium intake [ Time Frame: baseline, 2 months ]
    All patients will have office BP monitoring in the clinic in each visit
  • Number of patients with total adverse events, serious adverse events and death to assess tolerability of valsartan/amlodipine [ Time Frame: 2 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Efficacy and Safety of CVAA489 in Hypertensive Patients
Official Title  ICMJE A Single-Arm Open-Label Multicenter Phase IV Clinical Trial to Explore the Blood Pressure Lowering Effect of Exforge® (Amlodipine/Valsartan: AMLO/VAL) in Hypertensive Patients
Brief Summary The population that will be included in this study, will be regular Turkish hypertensive patients who are expected to consume sodium in high amounts. It is hypothesized that, in that population, amlodipine/valsartan will be effective at the same rate of blood pressure (BP) control rate as expected from literature.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Essential Hypertension
Intervention  ICMJE Drug: amlodipine/valsartan
Fixed combination of amlodipine and valsartan in tablet; 5/160/mg, 10/160 mg
Study Arms  ICMJE Experimental: amlodipine/valsartan
All patients will receive amlodipine/valsartan 5/160 mg daily in screening and up titrated to amlodipine/valsartan 10/160 mg daily at visit 2 (day 30) if their hypertension can not be controlled. The duration of treatment period is 8 weeks.
Intervention: Drug: amlodipine/valsartan
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: July 21, 2016)
115
Original Estimated Enrollment  ICMJE
 (submitted: February 12, 2014)
178
Actual Study Completion Date  ICMJE September 2015
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female, above 18 years of age
  • Diagnosis of essential hypertension
  • Newly diagnosed,
  • Previously untreated, or Currently untreated (not on regular antihypertensive treatment during the previous at least 1-month period)
  • Written informed consent

Exclusion Criteria:

  • Known or suspected secondary hypertension
  • eGFR lower than 30 mL/min
  • Use of any other hypertension treatments during the enrollment and need for using the related treatments during the study phase
  • History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes. (i.e. valsartan, amlodipine, hydrochlorothiazide)
  • History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
  • Use of other investigational drugs within 5 half-lives of enrollment, or within 30 days until the expected PD effect has returned to baseline, whichever is longer.Pregnant or nursing (lactating) women
  • Other protocol-defined inclusion/exclusion criteria may apply.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02062645
Other Study ID Numbers  ICMJE CVAA489ATR04
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date February 2017

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