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Trial record 25 of 101 for:    AMLODIPINE AND VALSARTAN
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Study of Efficacy and Safety of CVAA489 in Hypertensive Patients

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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 )

Study Description
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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.

Condition or disease Intervention/treatment Phase
Essential Hypertension Drug: amlodipine/valsartan Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 115 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : February 2014
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

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Arms and Interventions
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Arm Intervention/treatment
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.
 Drug: amlodipine/valsartan
Fixed combination of amlodipine and valsartan in tablet; 5/160/mg, 10/160 mg


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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)

  4. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
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): NCT02062645


Locations
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Turkey
Novartis Investigative Site
Ankara, Turkey, 06100
Novartis Investigative Site
Canakkale, Turkey
Novartis Investigative Site
Fatih / Istanbul, Turkey, 34098
Novartis Investigative Site
Kinikli / Denizli, Turkey, 20070
Novartis Investigative Site
Kocaeli, Turkey, 41380
Novartis Investigative Site
Malatya, Turkey, 44280
Novartis Investigative Site
Mersin, Turkey, 33079
Novartis Investigative Site
Talas / Kayseri, Turkey, 38039
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02062645     History of Changes
Other Study ID Numbers: CVAA489ATR04
First Posted: February 14, 2014    Key Record Dates
Results First Posted: March 28, 2017
Last Update Posted: March 28, 2017
Last Verified: February 2017
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
essential hypertension
Additional relevant MeSH terms:
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Amlodipine
Valsartan
Amlodipine, Valsartan Drug Combination
Hypertension
Essential Hypertension
Vascular Diseases
Cardiovascular Diseases
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