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Completed

NCT Number: NCT00415623

A Comparative Study Between Amlodipine 10mg And 5mg With Hypertension For Whom 5mg Is Insufficient

The changes in the trough systolic blood pressure from the baseline were assessed after 8 weeks of double-blind treatment with amlodipine 10 mg or amlodipine 5 mg

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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 3

Primary location

Pfizer Investigational Site, Kasuya-gun, Fujuoka, 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 Hypertensive Patients: An systolic blood pressure of >=160 mmHg or diastolic blood pressure >=100mmHg.
  • Treated Hypertensive Patients: An systolic blood pressure of >=140 mmHg or diastolic blood pressure of >= 90 mmHg.
  • Patients with insufficient response to 5 mg of amlodipine in the screening period:Two successive systolic blood pressure measurements at Visit 4 (Week -2) and Visit 5 (Week 0 = baseline) >=140 mmHg
  • Patients with a screening treatment compliance rate >= 80%

Exclusion criteria

  • Subjects with secondary hypertension (renal disease, pheochromocytoma, and Cushing's syndrome, etc.), severe hypertension (systolic blood pressure of 180 mmHg or higher, or diastolic blood pressure of 110 mmHg or higher), and malignant hypertension

Treatment and study plan

Amlodipine

Drug

Amlodipine 5mg/ day

Primary outcomes

  1. Change in Systolic Blood Pressure (SBP) From Baseline to Week 8

    Time frame: Baseline to Week 8

    Mean change in the trough SBP

Secondary outcomes

  1. Change in Diastolic Blood Pressure (DBP) From Baseline to Week 8

    Time frame: Baseline to Week 8

    Mean change in the trough DBP

  2. Combined Mean Change in SBP From Baseline to Week 6 and Week 8 (Mean by Patient)

    Time frame: Baseline to Week 6 and Week 8

    Arithmetic mean of Week 6 & Week 8 by patient for "Change from baseline in SBP at Week 6" and "Change from baseline in SBP at Week 8"

  3. Combined Mean Change in DBP From Baseline to Week 6 and Week 8 (Mean by Patient)

    Time frame: Baseline to Week 6 and Week 8

    Arithmetic mean of Week 6 & Week 8 by patient for "Change from baseline in DBP at Week 6" and "Change from baseline in DBP at Week 8"

  4. Number of Subjects Achieving the Target Blood Pressure Reduction Value at Week 8

    Time frame: Week 8

    Target blood pressure reduction value based on Japan Society of Hypertension Guidelines for the Management of Hypertension 2004: SBP below 130 mmHg and DBP below 85 mmHg for <=64 years old; SBP below 140 mmHg and DBP below 90 mmHg for >=65 years old

  5. Combined Number of Subjects Achieving the Target Blood Pressure Reduction Value at Both Weeks 6 and 8

    Time frame: Week 6 and Week 8

    Target blood pressure reduction value based on Japan Society of Hypertension Guidelines for the Management of Hypertension 2004: SBP below 130 mmHg and DBP below 85 mmHg for <=64 years old; SBP below 140 mmHg and DBP below 90 mmHg for >=65 years old

  6. Number of Subjects Achieving the Target Blood Pressure Reduction Value and Whose SBP Decreased From Baseline by >= 10 mmHg at Week 8

    Time frame: Week 8

    Target blood pressure reduction value based on Japan Society of Hypertension Guidelines for the Management of Hypertension 2004: SBP below 130 mmHg and DBP below 85 mmHg for <=64 years old; SBP below 140 mmHg and DBP below 90 mmHg for >=65 years old

  7. Combined Number of Subjects Achieving the Target Blood Pressure Reduction Value and Whose SBP Decreased From Baseline by >= 10 mmHg at Both Weeks 6 and 8

    Time frame: Week 6 and Week 8

    Target blood pressure reduction value based on Japan Society of Hypertension Guidelines for the Management of Hypertension 2004: SBP below 130 mmHg and DBP below 85 mmHg for <=64 years old; SBP below 140 mmHg and DBP below 90 mmHg for >=65 years old

  8. Trough Plasma Concentrations of Amlodipine -Amlodipine 5 mg

    Time frame: Baseline, Week 4 and Week 8

  9. Trough Plasma Concentrations of Amlodipine -Amlodipine 10 mg

    Time frame: Baseline, Week 4, and Week 8

Sponsors and collaborators

Lead sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Industry

Registry information

Official study title

A Double-Blind, Comparative Study Between Amlodipine 5mg And 10mg In Patients With Essential Hypertension For Whom Amlodipine 5mg Is Insufficiently Effective

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Dec 25, 2006
Registry last updated
Feb 11, 2021

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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