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NCT Number: NCT01518855

Controlled Release Nifedipine and Valsartan Combination Therapy in Patients With Essential Hypertension

The primary objective of this study is to investigate incremental cost effectiveness of Nifedipine CR and Amlodipine in combination therapy with Valsartan for the treatment of essential hypertensive patients.

To investigate incremental cost effectiveness, primary variables are mean treatment cost and achievement rate to target blood pressure level at the end of double-blind treatment period.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

20 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hiroshima, Japan

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Untreated patients or patients with previous treatment by antihypertensive agents whose blood pressure at sitting position at the time of the entry (Visit 1) is:

  • SBP>/=160mmHg or DBP>/=100mmHg for untreated patients (SBP Systolic blood pressure, DBP Diastolic blood pressure)
  • SBP>/=150mmHg or DBP>/=95mmHg for patients with previous treatment by antihypertensive agents

Exclusion criteria

  • Patients whose blood pressure on either day of Visit 1 or 2 is: SBP > 200mmHg or DBP > 120mmHg.
  • Patients with secondary hypertension or hypertensive emergency such as malignant hypertension.
  • Patients with a history of cardiovascular or cerebrovascular ischemic event (stroke, transient ischemic attack, myocardial infarction or unstable angina) within six months prior to the study.
  • Patients with a history of intracranial or subarachnoid hemorrhage within six months prior to the study.
  • Patients with uncontrolled diabetes (HbA1c >/=8%)
  • Patients with bradycardia or tachycardia (<50 bpm, >/=100 bpm), arrhythmia such as atrioventricular block (second and third degree), sinoatrial block or atrial fibrillation.

Treatment and study plan

Nifedipine (Adalat, BAYA1040)

Drug

Amlodipine (Norvasc)

Drug

Diovan

Drug

Primary outcomes

  1. Mean treatment cost* for 16-week of double-blind treatment period

    Time frame: 16 weeks

    • Including treatment cost for the drug related AEs. The sponsor will calculate the cost based on the tariff of health insurance scores.

  2. Proportion of participants** achieving target blood pressure at the end of double-blind treatment period

    Time frame: at week 16

    **For subjects aged under 60 years: SBP<130mmHg and DBP<85mmHg, for subjects aged 60 years or over: SBP<140mmHg and DBP<90mmHg (SBP Systolic blood pressure, DBP Diastolic blood pressure)

Secondary outcomes

  1. Treatment cost per subject to achieve the target blood pressure (Total costs for the double-blind treatment period / Number of patients who achieve the target blood pressure at the end of double-blind treatment period)

    Time frame: 16 weeks

  2. The change in blood pressure (SBP and DBP) from the baseline (end of pretreatment period) .

    Time frame: baseline to week 16

  3. Proportion of participants for each age group to target blood pressure level

    Time frame: at week 16

  4. Incidence of treatment-emergent drug-related adverse events

    Time frame: 16 weeks

  5. Safety variables will be summarized using descriptive statistics based on adverse events collections

    Time frame: 16 weeks

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Clinical Effect and Cost Effectiveness of Ca Antagonist in Combination With AII Receptor Antagonist in Patient With Essential Hypertension (PMS Study)

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Jan 26, 2012
Registry last updated
Jan 26, 2012

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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