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OpenTrials
Completed

NCT Number: NCT02062645

Study of Efficacy and Safety of CVAA489 in Hypertensive Patients

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.

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Key information

Conditions

Essential Hypertension Cardiovascular Diseases Hypertension Vascular Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novartis Investigative Site, Ankara, Turkey (Türkiye)

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Amlodipine/Valsartan

Drug

Fixed combination of amlodipine and valsartan in tablet; 5/160/mg, 10/160 mg

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Feb 14, 2014
Registry last updated
Mar 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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