FOCUS (Nifedipine GITS's Effect on Central Pressure Assessed by Applanation Tonometry)
This study has been completed.
Sponsor:
Bayer
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01071122
First received: February 18, 2010
Last updated: January 31, 2013
Last verified: January 2013
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Purpose
To determine whether the combination of nifedipine GITS and valsartan is more effective in reducing central blood pressure than nifedipine GITS or valsartan alone, and to determine whether nifedipine GITS is comparable to valsartan
| Condition | Intervention | Phase |
|---|---|---|
|
Hypertension |
Drug: Nifedipine (Adalat, BAYA1040) and Valsartan Drug: Nifedipine (Adalat, BAYA1040) Drug: Valsartan |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Prospective, Open-label, Active-controlled, Randomized Study Comparing Nifedipine GITS Versus Valsartan Versus a Combination of Both on Central Blood Pressure in Inadequately Controlled Essential Hypertension. |
Resource links provided by NLM:
Further study details as provided by Bayer:
Primary Outcome Measures:
- Central systolic blood pressure [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change in central diastolic blood pressure and pulse pressure [ Time Frame: Week 4,8 ] [ Designated as safety issue: No ]
- Change in central systolic blood pressure [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
- Change in brachial systolic blood pressure and diastolic blood pressure [ Time Frame: Week 4,8 ] [ Designated as safety issue: No ]
- Change in brachial pulse pressure [ Time Frame: Week4,8 ] [ Designated as safety issue: No ]
- Change in augmentation index and augmentation pressure [ Time Frame: Week 4,8 ] [ Designated as safety issue: No ]
- Response rate(≥10 mmHg decrease of brachial SBP and ≥5mmHg decrease of brachial DBP) [ Time Frame: Week 4,8 ] [ Designated as safety issue: No ]
- Control rate (≤140/90 mmHg, 130/80 mmHg for diabetes, of brachial BP [ Time Frame: Week 4,8 ] [ Designated as safety issue: No ]
| Enrollment: | 365 |
| Study Start Date: | January 2010 |
| Study Completion Date: | February 2012 |
| Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Arm 1 |
Drug: Nifedipine (Adalat, BAYA1040) and Valsartan
Combination treatment with nifedipine GITS 30mg and valsartan 80mg, Once daily
|
| Active Comparator: Arm 2 |
Drug: Nifedipine (Adalat, BAYA1040)
Nifedipine 60mg, Once daily
|
| Active Comparator: Arm 3 |
Drug: Valsartan
Valsartan 160mg, Once daily
|
Eligibility| Ages Eligible for Study: | 20 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Untreated grade 2 or grade 3 hypertension defined by mean diastolic blood pressure (BP) >/= 100 and/or mean systolic BP >/= 160mmHg without anti-hypertensive treatment or Treated grade 2 hypertension defined by mean diastolic BP >/= 100 and/or mean systolic BP >/=160mmHg with current diuretics and/or beta-blockers use for >/= 4 weeks
Exclusion Criteria:
- Secondary form of hypertension
- Mean systolic BP >/= 200mmHg and or mean diastolic BP >/= 120mmHg
- Treated with other antihypertensive medication except diuretics or beta-blockers
- Type 1 diabetes mellitus
- Known cardiovascular disease including history of angina pectoris, heart failure, history of myocardial infarction or revascularization procedure, or cerebrovascular disease (including stroke and transient ischaemic attack) within the previous 12 months
- Renal insufficiency defined as a serum creatinine: >/= 1.7 mg/dl
- Pregnancy or not using contraceptive in childbearing aged women
- Breast feeding women
- Any disease or condition that in the opinion of the investigator may interfere with completion of the study
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01071122
Locations
| Korea, Republic of | |
| Goyang, Gyeonggido, Korea, Republic of, 410-773 | |
| Goyang-si, Gyeonggido, Korea, Republic of, 411-706 | |
| Chungchungbuk-do, Korea, Korea, Republic of, 361-711 | |
| Seoul, Korea, Korea, Republic of, 135-720 | |
| Seoul, Seoul Teugbyeolsi, Korea, Republic of, 152-703 | |
| Busan, Korea, Republic of | |
| Gwangju, Korea, Republic of, 501-757 | |
| Joong-gu, Korea, Republic of, 100-380 | |
| Kungki-do, Korea, Republic of, 463-707 | |
| Seoul, Korea, Republic of, 110-744 | |
| Seoul, Korea, Republic of, 120-752 | |
| Seoul, Korea, Republic of, 135-710 | |
| Seoul, Korea, Republic of, 136-705 | |
| Seoul, Korea, Republic of, 137-701 | |
| Suwan, Korea, Republic of, 443-721 | |
Sponsors and Collaborators
Bayer
Investigators
| Study Director: | Bayer Study Director | Bayer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Medical Affairs Therapeutic Area Head, Bayer Healthcare AG |
| ClinicalTrials.gov Identifier: | NCT01071122 History of Changes |
| Other Study ID Numbers: | 14696 |
| Study First Received: | February 18, 2010 |
| Last Updated: | January 31, 2013 |
| Health Authority: | Korea: Food and Drug Administration |
Keywords provided by Bayer:
|
Central blood pressure Nifedipine Valsartan |
Additional relevant MeSH terms:
|
Hypertension Vascular Diseases Cardiovascular Diseases Nifedipine Valsartan Tocolytic Agents Reproductive Control Agents Physiological Effects of Drugs Pharmacologic Actions |
Therapeutic Uses Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Vasodilator Agents Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists Antihypertensive Agents |
ClinicalTrials.gov processed this record on June 18, 2013