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Effectiveness of Valsartan/Amlodipine (EXforge®) and Nifedipine treAtment coMparison in Treating Chinese Hypertensive Patients (EXAM)

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ClinicalTrials.gov Identifier: NCT01167153
Recruitment Status : Completed
First Posted : July 22, 2010
Results First Posted : June 1, 2012
Last Update Posted : June 1, 2012
Sponsor:
Information provided by (Responsible Party):
Novartis

Study Description
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Brief Summary:
The purpose of this study was to compare the efficacy and safety of Valsartan/Amlodipine (EXforge®) with nifedipine, as well as vascular function index.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Valsartan/Amlodipine Drug: Nifedipine Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 564 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A 12 Weeks, Multi-center, Open Label, Randomized, Active Drug Parallel Control Trial to Compare the Effectiveness of Valsartan/Amlodipine and Nifedipine in Treating Chinese Hypertensive Patients Not Respond to Mono Antihypertensive Treatment
Study Start Date : May 2010
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Valsartan/amlodipine
Valsartan/amlodipine 80/5 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
 Drug: Valsartan/Amlodipine
Valsartan/Amlodipine 80/5mg single pill combination (SPC)
Other Name: Exforge®
Active Comparator: Nifedipine
Nifedipine GITS (Gastro-Intestinal Therapeutic System ) 30 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
 Drug: Nifedipine
Nifedipine GITS (Gastro-Intestinal Therapeutic System ) 30 mg
Other Name: Adalat


Outcome Measures
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Primary Outcome Measures :
  1. Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at the Study End Point (12 Weeks) [ Time Frame: Baseline, 12 weeks ]
    The sitting blood pressure was trough value (23-26 hours after drug administration) measured by sphygmomanometer. Blood pressure was measured on both arms and the arm with higher mean sitting diastolic blood pressure (MSDBP) was used at visit 1 and following visits. Measurement of blood pressure was carried out 3 times at each visit on the selected arm. The results and mean value of three sitting blood pressures were recorded for analysis.

  2. Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at the Study End Point (12 Weeks) [ Time Frame: Baseline, 12 weeks ]
    The sitting blood pressure was trough value (23-26 hours after drug administration) measured by sphygmomanometer. Blood pressure was measured on both arms and the arm with higher msDBP was used at visit 1 and following visits. Measurement of blood pressure was carried out 3 times at each visit on the selected arm. The results and mean value of three sitting blood pressures were recorded for analysis.


Secondary Outcome Measures :
  1. Percentage of Patients With Effective Systolic Blood Pressure (SBP) Control Rate and Effective Diastolic Blood Pressure (DBP) Control Rate at the Study End Point (12 Weeks) [ Time Frame: Baseline, 12 weeks ]

    Effective SBP control rate was defined as proportion of subjects in whom MSSBP < 140 mmHg or MSSBP reduction ≥ 20 mmHg from baseline.

    Effective DBP control rate was defined as proportion of subjects in whom MSDBP < 90 mmHg or MSDBP reduction ≥10 mmHg from baseline.


  2. Percentage of Patients in Whom Blood Pressure Target Was Achieved at the Study End Point at 12 Weeks [ Time Frame: 12 weeks ]
    Blood Pressure (BP) target was defined as mean sitting BP<140/90 mm Hg in non-diabetic patients and<130/80 mm Hg in diabetic patients at 12 weeks.

  3. Change From Baseline in Orthostatic SBP and DBP at 12 Weeks [ Time Frame: Baseline, 12 weeks ]
    The arm with higher sitting blood pressure was selected for all examinations throughout the study. Orthostatic blood pressure was measured when subject stood for 1 minute. Orthostatic blood pressures were measured at screening and each visit.

  4. Change From Baseline in Sitting Pulse at 12 Weeks [ Time Frame: Baseline, 12 weeks ]
    Sitting pulse was measured by sphygmomanometer after subject sat for 5 minutes at clinic during each visit.

  5. Change From Baseline in Orthostatic Pulse at 12 Weeks [ Time Frame: Baseline, 12 weeks ]
    Orthostatic pulse was measured by sphygmomanometer when subject stood for 1 minute at clinic during each visit.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female adult outpatients had uncontrolled hypertension at both screening and randomization despite current antihypertensive monotherapy (initial dose of Angiotensin Receptor Blockers (ARB), Angiotensin Converting Enzyme Inhibitors (ACEI), Calcium Channel Blockers (CCB), diuretics or β receptor blocker)

Exclusion Criteria:

  • Systolic BP (SBP) level ≥160 mm Hg (≥160 mm Hg in diabetics) or a diastolic BP (DBP) level ≥110 mm Hg (≥100 mm Hg in diabetics) at any time between screening and randomization.
  • Patients with type 1 diabetes or poorly controlled type 2 diabetes (glycosylated hemoglobin >8.0%)
  • Patients had evidence of hepatic disease or renal impairment
  • Other exclusion criteria included evidence of secondary hypertension or history of cardio-vascular disease.
  • Women who were pregnant, nursing, or of childbearing potential and not using acceptable contraception.

Other protocol-defined inclusion/exclusion criteria applied.

Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT01167153


Locations
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China
Novartis Pharmaceuticals
Beijing, China
Sponsors and Collaborators
Novartis
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT01167153    
Other Study ID Numbers: CVAA489ACN02
First Posted: July 22, 2010    Key Record Dates
Results First Posted: June 1, 2012
Last Update Posted: June 1, 2012
Last Verified: May 2012
Keywords provided by Novartis:
Hypertension
Valsartan Amlodipine single pill combination
BP control
ABPM
Hypertensive patients not adequately controlled by mono antihypertensive drugs
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Valsartan
Nifedipine
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
 Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Tocolytic Agents
Reproductive Control Agents