Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
Trial record 10 of 101 for:    AMLODIPINE AND VALSARTAN

Efficacy and Safety of Valsartan and Amlodipine (± HCTZ) in Adults With Moderate, Inadequately Controlled Hypertension

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: NCT00523744
Recruitment Status : Completed
First Posted : August 31, 2007
Results First Posted : May 25, 2011
Last Update Posted : June 10, 2011
Sponsor:
Information provided by:
Novartis

Tracking Information
First Submitted Date  ICMJE August 30, 2007
First Posted Date  ICMJE August 31, 2007
Results First Submitted Date  ICMJE January 10, 2011
Results First Posted Date  ICMJE May 25, 2011
Last Update Posted Date June 10, 2011
Study Start Date  ICMJE July 2007
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 8, 2011)
  • Change in Mean Sitting Diastolic Blood Pressure (msDBP) During the Core Phase of the Study [ Time Frame: Baseline Phase 2 (Week 4) to end of Phase 2 (Week 8) ]
    The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic/diastolic blood pressure were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement.
  • Change in Mean Sitting Diastolic Blood Pressure (msDBP) During the Extension Phase of the Study [ Time Frame: Baseline Phase 3 (Week 8) to end of Phase 3 (Week 12) ]
    The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic/diastolic blood pressure were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement.
Original Primary Outcome Measures  ICMJE
 (submitted: August 30, 2007)
Diastolic blood pressure change when using aml + val in patients not adequately responding (mean sitting diastolic blood pressure >= 90 mmHg) to 4 weeks of treatment with aml+olmesartan.
Change History Complete list of historical versions of study NCT00523744 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 8, 2011)
  • Change in Mean Sitting Systolic Blood Pressure (msSBP) During the Core Phase of the Study [ Time Frame: Baseline Phase 2 (Week 4) to end of Phase 2 (Week 8) ]
    The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic/diastolic blood pressure were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement.
  • Change in Sitting Pulse Pressure During the Core Phase of the Study [ Time Frame: Baseline Phase 2 (Week 4) to end of Phase 2 (Week 8) ]
    Pulse pressure is systolic pressure (SP) minus diastolic pressure (DP). The arm in which the highest sitting DPs were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, SP and DP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement.
  • Change in Sitting Pulse Rate During the Core Phase of the Study [ Time Frame: Baseline Phase 2 (Week 4) to end of Phase 2 (Week 8) ]
    Pulse rate was measured once for 30 seconds just prior to blood pressure measurements in the sitting position.
  • Percentage of Patients Who Achieved Normalized Blood Pressure During the Core Phase of the Study [ Time Frame: Baseline Phase 2 (Week 4) to end of Phase 2 (Week 8) ]
    Normalized Blood Pressure was defined as a msSBP < 140 mmHg and/or a msDBP < 90 mmHg.
  • Percentage of Patients Who Achieved a Protocol-defined Blood Pressure Response During the Core Phase of the Study [ Time Frame: Baseline of Phase 2 (Week 4) to end of Phase 2 (Week 8) ]
    Blood pressure response was defined as msSBP < 140 mmHg or a 20 mmHg decrease in msSBP at the end of Phase 2 (Week 8) compared to Baseline in Phase 2 (week 4) or a msDBP < 90 mmHg or a 10 mmHg decrease in msDBP at the end of Phase 2 compared to Baseline in Phase 2.
  • Change in Mean Sitting Systolic Blood Pressure (msSBP) During the Extension Phase of the Study [ Time Frame: Baseline Phase 3 (Week 8) to end of Phase 3 (Week 12) ]
    The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic/diastolic blood pressure were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement.
  • Change in Sitting Pulse Pressure During the Extension Phase of the Study [ Time Frame: Baseline Phase 3 (Week 8) to end of Phase 3 (Week 12) ]
    Pulse pressure is systolic pressure (SP) minus diastolic pressure (DP). The arm in which the highest sitting DPs were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, SP and DP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement.
  • Change in Sitting Pulse Rate During the Extension Phase of the Study [ Time Frame: Baseline Phase 3 (Week 8) to end of Phase 3 (week 12) ]
    Pulse rate was measured once for 30 seconds just prior to blood pressure measurements in the sitting position.
  • Percentage of Patients Who Achieved Normalized Blood Pressure During the Extension Phase of the Study [ Time Frame: Baseline Phase 3 (Week 8) to end of Phase 3 (Week 12) ]
    Normalized Blood Pressure was defined as a msSBP < 140 mmHg and/or a msDBP < 90 mmHg.
  • Percentage of Patients Who Achieved a Protocol-defined Blood Pressure Response During the Extension Phase of the Study [ Time Frame: Baseline of Phase 3 (Week 8) to end of Phase 3 (Week 12) ]
    Blood pressure response was defined as msSBP < 140 mmHg or a 20 mmHg decrease in msSBP at the end of Phase 3 compared to Baseline in Phase 3 or a msDBP < 90 mmHg or a 10 mmHg decrease in msDBP at the end of Phase 3 compared to Baseline in Phase 3.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 30, 2007)
SBP, pulse, heart rate, mean sitting systolic blood pressure < 140 mmHg and/or a mean sitting diastolic blood pressure < 90 mmHg) and responder rate (MSSBP < 140 mmHg or >= 20 mmHg decrease in mean sitting systolic blood pressure
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Valsartan and Amlodipine (± HCTZ) in Adults With Moderate, Inadequately Controlled Hypertension
Official Title  ICMJE An Open-label, Multicenter Study to Evaluate the Efficacy and Tolerability of a 4 Week Therapy With the Fixed Dose Combination of Amlodipine 10 mg Plus Valsartan 160 mg in Hypertensive Patients Not Adequately Responding to a 4 Week Therapy With the Free Combination of an Angiotensin Receptor Blocker (Olmesartan 20 mg) Plus Amlodipine 10 mg
Brief Summary This study will evaluate the efficacy and safety of valsartan and amlodipine in fixed dose combination in adults with moderate, inadequately controlled hypertension. There was an optional study extension for eligible patients who wanted to participate that contains the triple therapy (ie, hydrochlorothiazide+ amlodipine/valsartan).
Detailed Description Title of study extension: An open-label, multicenter extension to evaluate the efficacy and tolerability of a 4 week therapy with hydrochlorothiazide 12.5 mg plus amlodipine 10 mg/valsartan 160 mg in hypertensive patients not adequately responding to a 4 week therapy each with the combinations of olmesartan 20 mg plus amlodipine 10 mg followed by amlodipine 10 mg/valsartan 160 mg
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hypertension
Intervention  ICMJE
  • Drug: Amlodipine
    Amlodipine supplied as 5 mg tablets, taken orally once a day during Treatment Phase 1 only.
  • Drug: Olmesartan medoxomil
    Olmesartan medoxomil supplied as 10 mg tablets taken once a day during Treatment Phase 1 only.
  • Drug: Amlodipine+valsartan
    Fixed-dose combination of amlodipine 10 mg plus valsartan 160 mg tablet taken orally once a day during Treatment Phase 2 and Extension Phase.
    Other Name: Exforge
  • Drug: Hydrochlorothiazide
    Hydrochlorothiazide (HCTZ) 12.5 mg tablets taken once a day during the Extension Phase.
    Other Name: Sandoz
Study Arms  ICMJE Experimental: Amlodipine(AML)+olmesartan, AML+valsartan, AML+valsartan+HCTZ
During the Treatment Phase 1, participants received 1 week of treatment with olmesartan 10 mg and amlodipine 5 mg once daily in free combination, followed by three weeks of treatment with olmesartan 20 mg plus amlodipine 10 mg once daily in free combination. During the treatment Phase 2 of the study participants received amlodipine 10 mg plus valsartan 160 mg for 4 weeks. During the Extension Phase, participants received 4 weeks treatment with amlodipine 10 mg plus valsartan 160 mg plus hydrochlorothiazide (HCTZ) 12.5 mg.
Interventions:
  • Drug: Amlodipine
  • Drug: Olmesartan medoxomil
  • Drug: Amlodipine+valsartan
  • Drug: Hydrochlorothiazide
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: April 25, 2011)
257
Original Estimated Enrollment  ICMJE
 (submitted: August 30, 2007)
240
Actual Study Completion Date  ICMJE December 2007
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria for Core study:

  • Male or female patients (>=18 years)
  • Females must be either post-menopausal for one year, surgically sterile or using effective contraceptive methods
  • Patients with essential hypertension (diastolic blood pressure >=100 mmHg and <110 mmHg)

Inclusion Criteria for Extension:

- Patients had to have a msSBP >= 140 mmHg and/or msDBP >= 90 mmHg at week 8 ie, end of core study.

Exclusion Criteria for Core study:

  • Severe hypertension (diastolic blood pressure >=110 mmHg or systolic blood pressure >= 180 mmHg)
  • Pregnant or nursing women
  • Treated hypertensive patients with controlled hypertension under current therapy
  • A history of cardiovascular disease, including angina pectoris, myocardial infarction, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, transient ischemic attack, stroke, and heart failure NYHA II - IV

Exclusion Criteria for Extension:

  • prematurely discontinued the core study
  • failed to comply with the core study protocol

Other protocol-defined inclusion/exclusion criteria applied to the study.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00523744
Other Study ID Numbers  ICMJE CVAA489ADE06
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
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Pharmaceuticals Sponsor GmbH
PRS Account Novartis
Verification Date June 2011

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