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OpenTrials
Completed

NCT Number: NCT00698646

Efficacy and Safety of Valsartan/Hydrochlorothiazide Combination Compared to Valsartan Monotherapy or Hydrochlorothiazide Monotherapy in Elderly (>70) With Mild-moderate Hypertension.

The purpose of the study is to evaluate the safety and efficacy of initial treatment therapy with valsartan/hydrochlorothiazide (HCTZ) versus the initial treatment therapy with monotherapies (valsartan or HCTZ) in the very elderly patients (greater than or equal to 70 years) with stage 1 or 2 hypertension

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Investigative site, Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 70 years or older.
  • Patients with hypertension prior to being randomized into study.
  • Patients must have an office cuff MSSBP ≥ 140 and ≤ 200 mmHg systolic.
  • Have the ability to communicate and comply with all study requirements.
  • Provide written informed consent to participate in the study prior to any screening or study procedures.

Exclusion criteria

  • Use of other investigational drugs within 30 days of enrollment.
  • History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes.
  • Office blood pressure measured by office machine cuff with a mean of (3) MSDBP ≥ 120 mmHg at anytime during the screening / washout period.
  • Patients taking 3 or more antihypertensive drugs and MSSBP ≥ 160 mmHg at the time of Visit 1.
  • Other protocol-defined exclusion criteria may apply

Treatment and study plan

Valsartan + HCTZ

Drug

At week 0 patients received V+HCTZ 160+12.5 mg capsules. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 320+12.5 mg at week 4 and if needed to V+HCTZ 320+25 mg at week 8 or 12.

valsartan

Drug

At week 0 patients received Valsartan(V) 160 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12.

HCTZ

Drug

At week 0 patients received HCTZ 12.5 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12.

Primary outcomes

  1. Change From Baseline to Week 4 in Office Cuff Mean Sitting Systolic Blood Pressure (MSSBP)

    Time frame: Baseline and Week 4

Secondary outcomes

  1. Change From Baseline to Week 4, 8, 12 and 16 in Office Cuff Mean Sitting Diastolic Blood Pressure (MSDBP)

    Time frame: Baseline and Weeks 4, 8, 12 and 16

  2. Change From Baseline to Weeks 8, 12 and 16 in Office Cuff Mean Sitting Systolic Blood Pressure (MSSBP)

    Time frame: Baseline and Weeks 8, 12, and 16

  3. Cumulative Percentage of Patients Achieving the Blood Pressure Control of < 140/90 mmHg

    Time frame: Weeks 4, 8, 12 and 16

    Cumulative refers to achieving of blood pressure control before or at the corresponding visit.

  4. Cumulative Percentage of Patients Achieving Blood Pressure Goal (MSSBP < 140 mmHg)

    Time frame: Weeks 4, 8, 12 and 16

    Cumulative refers to achieving blood pressure goal before or at the corresponding visit.

  5. Time in Weeks to Achieving the First Treatment Success (Defined as the Time of the First Achievement of the Target Blood Pressure Goal [MSSBP/MSDBP <140/90 mmHg])

    Time frame: During 16 weeks

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

A 16 Week Multi-center, Randomized, Double-blind Study to Evaluate Efficacy and Safety of Valsartan/Hydrochlorothiazide (HCTZ) Combination Therapy Compared to Patients Initiated With Valsartan Monotherapy or Hydrochlorothiazide (HCTZ) Monotherapy in Very Elderly Patients With Essential Hypertension

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jun 17, 2008
Registry last updated
Apr 19, 2011

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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